Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Inflammation

Depression

Depressive Disorder

Fatigue

Dyssomnias

Parasomnias

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with 5 minutes and increasing to 20 minutes over the course of the 6-week intervention - as is standard with the Mindfulness Awareness Practices (MAPs) course - with practice prior to bedtime. An intervention training manual is the cornerstone of standardized delivery of MAP-I. Participants are also provided with a book on mindfulness (Fully Present: The Science, Art, and Practice of Mindfulness, authored by the Mindfulness Awareness Research Center (MARC) leader and MAP-I instructor Diana Winston) as well as access to the University of California Los Angeles (UCLA) Mindful App courtesy of the MARC at UCLA (via personal iPhone or study-administered tablets per patient preference), which contains pre-recorded guided meditations for use in daily practice.

Six individual 1-hour videos will be shown to participants at the same time points as, and with equal duration to, the MAP-I intervention. These videos will be recorded presentations that have been modified for HCT recipients based upon similar SHE interventions delivered in prior studies. Similar to the intervention group, patients in the SHE group will also participate in group Zoom chat sessions with equal frequency and duration lead by a study research coordinator. These sessions will allow for general patient interaction to discuss sleep and any questions or comments they may have, as lead by the group facilitator.

MAP-I is a curriculum-based intervention that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan.

Mindfulness Awareness Practices for Insomnia

A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.

Sleep Health Information

Cancer Center Clinical Trials Office

Jennifer Knight, MD

This randomized, controlled study will compare Mindfulness Awareness Practices for Insomnia (MAP-I) to sleep health education (SHE) in subjects receiving autologous hematopoietic cell transplant for multiple myeloma.

This randomized controlled study will evaluate the feasibility of implementing a mindfulness intervention targeting inpatient autologous hematopoietic cell transplantation (HCT) recipients (first HCT) with multiple myeloma (MM) and the preliminary efficacy of Mindfulness Awareness Practices for Insomnia (MAP-I) vs. sleep health education (SHE) to improve insomnia outcomes, cellular and transcriptomic markers of inflammation, and insomnia associated behavioral symptoms (depression, fatigue).

Patients enrolled in this study will be randomized to either receive MAP-I or SHE starting 2-4 weeks prior to HCT. Patients will receive two sessions prior to inpatient admission for HCT, and four sessions in the two weeks of hospitalization following HCT, for a total of six intervention (or control) sessions.

Primary Objective: Determine the feasibility of implementing MAP-I among HCT recipients under first autologous HCT for MM.

Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes

Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms

This outcome measure is the number of participants signed consent and were enrolled compared to the number of potential participants assessed for eligibility.

This outcome measure is the number of participants completing the required study procedures compared to the number of participants initiating study procedures.

Medical College of Wisconsin

Assistant Professor

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Etoposide

Cytarabine

Lenograstim

Etoposide phosphate

Busulfan

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

1. Patient with CBF AML will be eligible in his/her 1st complete remission (CR1) status. Patients who have relapsed or have achieved 2nd complete remission should not be included in this study.
2. 1st postremission therapy after CR1 will be performed with high-dose cytarabine (HDAC) chemotherapy, consisting of intravenous cytarabine 3 g/m2 infusion during 3 hours twice a day on days 1, 3, and 5.
3. After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.

1. Autologous peripheral blood stem cell (PBSCs) harvesting

   * After the second cycle of high-dose ara-C(HDAC) consolidation chemotherapy
   * Mobilization: recombinant human G-CSF(Filgrastim) 5mcg/kg s.c. daily starting on 10 days after start of the second cycle of HDAC chemotherapy
   * Harvest procedure: peripheral blood mononuclear cells will be collected. Target CD34+ cell dose is over 5x10E6/kg.
2. Conditioning regimen for autologous HCT

   * Busulfan 3.2 mg/kg/day i.v. daily on days -7 to -5 (for 3 days)
   * Etoposide 400mg/m2/day i.v. daily on days -3 to -2 (for 2 days)
3. Autologous cell infusion and waiting for engraftment

autologous hematopoietic cell transplantation

Mijin Jeon, RN, CNS

Mi Ryang Jang, RN

Yeonghui Park, RN

Hyeok Shim, M.D. & PhD.

Hyeok Choi, RN

Gyeong Won Lee, M.D. & PhD.

Hyo Jung Kim, M.D. & PhD.

Dae Young Zang, M.D. & PhD.

Aeran Lee, RN

Yang Soo Kim, M.D. & PhD.

Seong-Hoon Shin, M.D. & PhD.

Ho-Sup Lee, M.D. & PhD.

Hyejung Eum, RN

Young-Don Joo, M.D. & PhD.

Won-Sik Lee, M.D. & PhD.

Jung-eun Lee, RN

Jung-lim Lee, M.D. & PhD.

Sun-ah Lee, M.D. & PhD.

Young Mi Chun, RN

Myung Soo Hyun, M.D. & PhD.

Min Kyoung Kim, M.D. & PhD.

Hun Mo Ryoo, M.D. & PhD

Sung Hwa Bae, M.D. & PhD

Jin Hee Park, M.D. & PhD.

Mijin Jeon, RN

Kyoo-Hyung Lee, M.D. & PhD

Je-Hwan Lee, M.D. & PhD

Jung-Hee Lee, M.D. & PhD.

Dae-Young Kim, M.D.

Mi-young Kim, RN

Eun-hee Lee, RN, CNS

Jae-Hoo Park, M.D. & PhD.

Young Joo Min, M.D. & PhD.

Hawk Kim, M.D. & PhD.

Je-Hwan Lee, MD, PhD

Primary study objective is the evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and disease-free survival (DFS).

Secondary study objectives are the engraftment rate / time to engraftment, transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall survival (OS).

1. BACKGROUND AND RATIONALE 1.1. CLINICAL CHARACTERISTICS OF CBF AML Acute myeloid leukemia (AML) is a disease entity consisting of heterogeneous groups with different clinical features and prognosis. Cytogenetic status of patients with AML is the single most important factor to expect the survival and the treatment responses.

Core binding factor (CBF) AML is characterized by the presence of cytogenetic abnormalities, i.e., the balanced translocation between chromosome 8 and 21 \[t(8;21)(q22;q22)\] and the pericentric inversion of chromosome 16 \[inv(16)(p13q22)\] or its less frequent variant, the balanced translocation t(16;16)(p13;q22). Among adults with de novo AML, t(8;21) and inv(16) are found in 7% and 8% of patients, respectively1. All the subtypes of CBF AML share the same chimeric fusion genes that are formed by the disruption of genes encoding different subunits of the core binding factor, a heterodimeric transcription factor complex.

CBF AML has been accepted as a disease entity of favorable prognosis with a high complete remission rate (up to 90%) with conventional induction chemotherapy followed by an intensive consolidation treatment of 3 or 4 cycles of high-dose cytarabine(HDAC). The overall survival of patients in this group rise up to 60 - 70 %, and this encouraging result has supported the opinion that HDAC was a more preferable postremission therapy instead of autologous hematopoietic cell transplantation (HCT) or allogeneic HCT.

1.2. STRATEGY TO REDUCE RELAPSE IN CBF AML It has been thought that patients with CBF AML in first complete remission (CR1) would benefit most from high-dose consolidation chemotherapy and the risk of HCT outweigh the benefit in this group. However, the cumulative incidence of relapse (CIR) has been reported to be up to 54% and 50-60% of patients are cured using contemporary treatment. The survival outcome is unsatisfactory, especially in elderly patients. Prebet et al reported that the 5-year probabilities of overall survival (OS) and leukemia-free survival (LFS) were 31% and 27%, respectively with intensive consolidation or low-dose maintenance chemotherapy among patients with CBF AML who were age 60 years or older. To improve the treatment outcome in this group, alternative strategies of postremission therapy with more efficiency and more tolerability are warranted, especially for patients who are prone to relapse. A number of studies about the stratified intensification of postremission therapy according to the risk of relapse and the appropriate prognostic index for identifying high risk patients have been reported, and some of them are currently under investigation.

1.3. DIFFERENCES BETWEEN AML WITH INV(16) AND WITH T(8;21) Recent studies have reported that these two groups seem to be distinct clinical entities and should be stratified and reported separately. Patients with t(8;21) had shorter OS (hazard ratio \[HR\] =1.5, p=0.045) and survival after first relapse (HR=1.7, p=0.009) than patients with inv(16). A similar difference was found among patients who had undergone HCT; the 3-year OS of patients with t(8;21) and inv(16) was 50% and 72%, respectively(p=0.002). Based on these results, a discriminative postremission strategy could be applied to patients with CBF AML - patients with t(8;21) should be managed differently from those with inv(16) as to the application of HCT and a prospective trial can be warranted to clarify the significance of HCT over chemotherapy.

1.4. RISK STRATIFICATION IN AML WITH INV(16) Although AML with inv(16) has a relatively good prognosis, a substantial number of these patients (i.e. 40-50%) finally relapse. In this group, timely identification and therapeutic stratification of patients who deemed at high risk for relapse could ultimately result in an improvement of clinical outcomes. The minimal residual disease (MRD) monitoring with real-time quantitative polymerase chain reaction (RQ-PCR) assays for CBFβ/MYH11 fusion transcript has been regarded as a useful surrogate marker for identifying a patient with resistant disease and for predicting relapse early during remission. Lane et al reported that a rise of the same or more than 1 log rise of transcript level relative to the level from a remission bone marrow sample at any time of post-induction follow up correlated with inferior LFS and morphologic relapse (HR 8.6). Bounamici et al suggested that patients whose transcript ratios of bone marrow samples taken during remission were greater than 0.25% finally relapse, and ratio below 0.12% might indicate that patients is in a curable state.

Two conclusions can be deduced from the results above; first, a considerable portion of patients among those with CBF AML finally relapse. Second, post-induction MRD monitoring might be helpful in discriminating patients who are vulnerable to relapse and may have benefit with more intensified consolidation therapy.

1.5. RISK STRATIFICATION IN AML WITH T(8;21) AML with t(8;21) has been accepted as a disease of good prognosis and categorized to favorable cytogenetic risk group along with AML with inv(16). According to recent studies, however, outcomes of AML patients with t(8;21) were disappointing in contrary to those with previous ones. The biologic and prognostic heterogeneity have been recently described for this subgroup (including other subtypes of CBF AML) and a number of promising biologic markers have been suggested.

MRD monitoring with RQ-PCR or flow cytometry is also thought as a useful method for the stratification of patients with t(8;21), as well as for those with inv(16). C-kit mutation has been generally accepted as a discriminating marker of CBF AML which increase the relapse risk. A difference in race has been considered as an important predictor for t(8;21) AML, in that nonwhites failed induction more often and had shorter OS than white. Other biomarkers which has been being considered are leukocyte count or white blood cell, CD56 positivity, loss of sex chromosome and secondary cytogenetic abnormalities6, submicroscopic deletion during chromosome rearrangement, loss of MRP gene during translocation / inversion and presence of RAS/FLT3 mutation. Gene-expression profile is suggested as a relevant way of molecular characterization to discriminate substantial biologic and clinical heterogeneity within CBF AML.

1.6. COMPARISON OF POSTREMISSION THERAPY FOR CBF AML The optimal postremission therapy of CBF AML remains to be determined. Despite being considered as patients in more favorable risk group in AML, only approximately half of the patients are cured with current strategy, significant portion of patients finally relapse and the overall survival is unsatisfactory. Heterogeneity of the treatment outcome in this group also suggests that a tailored approach might be preferred to a unique predefined strategy to treat. Current state of CBF AML indicates the need for improved therapeutic approaches, including more intensive consolidation to obtain improved LFS.

There were a few prospective studies that support the role of HCT. A prospective trial on the impact of cytogenetics and the kind of consolidation therapy performed by Visani et al showed that patients in the favorable group had significantly longer disease-free survival(DFS) when treated with an intensive induction and allogeneic HCT as an intensive consolidation therapy. According to the result of MRC AML 10 randomized controlled trial comparing the addition of autologous HCT with intensive chemotherapy alone for AML in CR1, addition of autologous HCT to four course of intensive chemotherapy reduced the risk of relapse, increased disease-free survival significantly, and improved the overall survival, although there were more death in remission in the autologous HCT group. However, a number of studies support the classic concept that CBF AML in CR1 would benefit most from HDAC and the risk of HCT outweigh the benefit. Delaunay et al reported that outcome of patients with inv(16) in CR1 was similar among patients allocated to receive allogeneic HCT vs HDAC8. According to the meta-analysis performed on 392 adults with CBF AML in prospective German AML treatment trial, type of postremission therapy revealed no difference between intensive chemotherapy and autologous HCT in the t(8;21) group and between chemotherapy, autologous HCT, and allogeneic HCT in the inv(16) group. Recent results suggest the possibility of improving overall survival with HCT. Subgroup analysis of EORTC-LG/GIMEMA AML-10 trial in which patients younger than 46 years were assigned to allogeneic HCT or autologous HCT according to the availability of HLA-identical sibling donor, DFS rate were similar in patients with good risk cytogenetics. Kuwatsuka et al reported a retrospective analysis on the results of HCT performed on CBF AML. OS was not different between patients in CR1 who received allogeneic HCT and those who received autologous HCT for both t(8;21) AML (84% vs 77%; p=0.49) and inv(16) AML (74% vs 59%, p=0.86).

1.7. OPTIMAL POSTREMISSION THERAPY FOR CBF AML In summary, HDAC chemotherapy has been recommended as a relevant postremission therapy for patients with CBF AML in CR1 on the basis that risk of HCT outweigh the clinical benefit of reducing the incidence of relapse and prolonging LFS. With the advances in hematopoietic cell transplantation technique and biomarkers for risk stratification, HCT is now considered for a promising method to improve the overall outcome of patients with CBF AML. Until now, previous results support the introduction of autologous HCT rather than allogeneic HCT for intensified postremission therapy in CBF AML in that the benefit of HCT was not yet proven and the risk of allogeneic HCT might outweigh the benefit in this group. We hereby intend to evaluate the efficacy of autologous HCT in patients with CBF AML in CR1.

Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia

Phase 2 Study of Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission

defined as the interval between the day when complete remission is confirmed with bone marrow biopsy report (not by the day when bone marrow biopsy was performed) and the day when the relapse is confirmed by bone marrow biopsy or the presence of peripheral blood.

defined as the interval between day 0 (PBSCs infusion) and the first day of evidence for engraftment.

defined as the interval between day 0-PBSCs infusion and the event.

measured from day 0 to the date of last follow-up or death.

Asan Medical Center

Professor

Vaccines

Heptavalent Pneumococcal Conjugate Vaccine

BIRC5 protein, human

Adjuvants, Immunologic

Dendritic Cell Survivin Vaccine (DC:AdmS) and Autologous Hematopoietic Cell Transplantation (HCT). Participants will receive 1 pre-transplant survivin vaccine, 7-30 days prior to stem cell apheresis collection. After the first survivin vaccination, participants will be mobilized with Granulocyte-colony Stimulating Factor (G-CSF). A second survivin vaccine will be administered on day +21 (between day+20 and +34) after HCT. All participants will be co-immunized with Prevnar 13 at each time they receive the survivin vaccine.

Pre-transplant vaccination : The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, Human Leukocyte Antigen - antigen D Related (HLA-DR)+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered.

Post-transplant vaccination: The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, HLA-DR+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered.

Survivin Vaccine

The participant's own cells are collected from their blood, frozen, and then given back to them after they receive chemotherapy.

Autologous Hematopoietic Cell Transplantation

13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine. This vaccine will be administered intramuscular (IM) 0.5cc.

Prevnar 13

After the first survivin vaccination, participants will be mobilized with G-CSF.

Granulocyte-colony Stimulating Factor

Frederick Locke, M.D.

The purpose of this study is to test what effects (good and bad) a new cancer vaccine will have on participants and their cancer, when administered before and after their autologous hematopoietic cell transplant (HCT).

The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is made using the participant's own blood cells. The vaccine will contain a virus called an adenovirus, similar the virus that causes the common cold. The virus has been changed so it cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer Center in the Cell Therapy Laboratory Facility.

This study is designed to test the safety and efficacy of the survivin vaccine, as well as the biological activity. A total sample size of 30 patients will be used for the study. In the 1st stage, 10 patients will be used to evaluate the safety and futility of the vaccine. If it passes the 1st stage, investigators will enroll another 20 patients (as 2nd stage) to evaluate the efficacy. The two- stage experiment is based on Simon minmax two-stage design for efficacy. Vaccine will be administered in two stages. After the first survivin vaccination, participants will be mobilized with G-CSF and both in vivo-primed T cells and stem cells will be collected in the same apheresis (the graft). T cells and the CD34 progenitor cells will be transferred back to the participant at the time of autologous graft infusion. Participants will receive re-vaccination on, or near, day 21 after transplant.

Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)

Evaluating the Safety and Biological Activity of a Dendritic Cell Survivin Vaccine in Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplantation

Complete Response: A treatment outcome where there are ≤5% plasma cells in the bone marrow and no evidence of myeloma proteins in the serum or urine as measured by standard laboratory techniques.

The safety of DC:AdmS when administered to patients with myeloma before and at day +21 after autologous hematopoietic stem cell transplant. The approach for assessing potential toxicity of survivin vaccination will focus predominantly on assessing hematopoietic reconstitution, including T cell repopulation and gastrointestinal toxicity. Investigators will also monitor for autoimmune disorders involving other tissues where survivin expression has been demonstrated: these include keratinocytes and melanocytes, myocardium, liver, breast, and brain. The most sensitive test to assess the potential toxicity of survivin vaccination on hematopoietic function is the time of neutrophil repopulation after autologous stem cell transplant (ASCT). Beginning on day of ASCT, participants will be monitored daily for engraftment, defined by an absolute neutrophil count of 500 cells per microliter that is sustained for at least 3 days.

The ability of DC:AdmS to induce T cell immune responses against survivin when administered to patients with myeloma before and at day +21 after autologous hematopoietic stem cell transplant.

Immunologic responses: be measured at baseline prior to the first vaccination (i.e., baseline), after stem cell mobilization and collection (i.e., pre-transplant), and post-transplant at day +60, +90, and +180. Each time 100 cc of peripheral blood will be collected. Immune response evaluations will consist of the following: Determination of the survivin specific T cell frequency using limiting dilution analysis and freely available online software; Analysis of Interferon-γ producing T cells in ELISPOT assays in response to DC loaded survivin peptide pool; Measurement of anti-pneumococcal immunoglobulin G (IgG) antibody titers and T cell responses against cross-reacting material (CRM) adjuvant; Evaluation of immunomodulatory phenotypes by T cell subsets before and after vaccination.

H. Lee Moffitt Cancer Center and Research Institute

Nutritional and Metabolic Diseases

Protein-Energy Malnutrition

Plerixafor

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Filgrastim

Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.

Apheresis

Jennifer Kanakry, M.D.

Background:

- One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant.

Objectives:

- To collect stem cells for transplant as part of treatment for plasma cell myeloma.

Eligibility:

- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood.
* Participants will have apheresis to collect the stem cells.
* Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.

Background:

High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) remains a critical part of the Plasma Cell Myeloma (PCM) treatment in subjects eligible for the procedure. The timing of the procedure however, has become more controversial recently. This protocol will allow collection of Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) in potential candidates for various PCM protocols at the Clinical Center.

The mobilizing agent plerixafor (Mozobil, Genzyme) has been recently approved by the Food and Drug Administration (FDA) for mobilization in PCM. However, the best and most cost effective strategy for its use remains to be defined.

Objectives:

Evaluate the overall validity of an HPC mobilization strategy (with granulocyte-colony stimulating factor (G-CSF) alone or in combination with plerixafor) using a formula calculating the likelihood of collecting greater than or equal to 5 time 10\^6 cluster of differentiation 34 (CD34) plus cells/kg in a single mobilization cycle.

Collect mobilized Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) prior to AHCT for PCM

Eligibility:

Subjects with a possible indication for AHCT for the treatment of newly diagnosed PCM.

Subjects with recurrent or persistent evaluable disease who have not undergone AHCT for the treatment of the PCM.

Design:

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Mobilization will be provided by a 5-daily administration of filgrastim according to standard procedure.

The need for an additional mobilizing agent (plerixafor) to be given on day 4 of mobilization will be evaluated in real time in each patient, based on the peripheral blood CD34 count on the morning of day 4 of filgrastim administration.

Study accrual over a 3-year period: 70 subjects

Collection of Transplant Stem Cells for Plasma Cell Myeloma

Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)

Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE\^6/kg following apheresis.

Progenitor cells by apheresis was determined by flow cytometry.

The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all

Here is the percentage of patients that achieved or did not achieve 5 x 10\^6 CD34 cells/kg in a single apheresis.

Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.

Flow cytometry to detect tumor contamination.

National Cancer Institute (NCI)

Principal Investigator

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.

Hematopoietic Progenitor Cells

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106\^ CD34+ cells/kg.

Hematopoietic Progenitor Cells (HPC)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The sample size in outcome measure number 6 was inadequate. Results were not conclusive and the information is determined to be too preliminary to present. No conclusion should be drawn from the reported data for this outcome.

Dr. Jennifer Kanakry

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10\^6 CD34+ cells/kg.

Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis

Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight

Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))

Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)

Range of Cluster of Differentiation 34 (CD34) Cells Collected

25th percentile

75th percentile

25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected

Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)

Number of Participants With Serious and Non-Serious Adverse Events

Plerixafor + G-CSF

Only G-CSF (no plerixafor)

Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)

Achieved 5 x 10EE CD34 cells/kg

Did not achieve 5 x 10EE CD34 cells/kg

Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg

Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)

No data from any participant was sufficiently collected to assess tumor cell contamination.

Degree of Tumor Cell Contamination in the Final Product

Because no data from any participant was sufficiently collected to assess tumor cell contamination, we were not able to determine the effect of plerixafor on this parameter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes	NCT04271930	Sleep Multiple Myelom...	Mindfulness Awa... Sleep Health In...	18 Years -	Medical College of Wisconsin
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia	NCT01050036	Leukemia, Myelo...	autologous hema...	15 Years - 65 Years	Asan Medical Center
Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)	NCT02851056	Multiple Myelom...	Survivin Vaccin... Autologous Hema... Prevnar 13 Granulocyte-col...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Effect of Sleep Quality on Hematopoietic Cell Transplant Patient Outcomes	NCT04271930	Sleep Multiple Myelom...	Mindfulness Awa... Sleep Health In...	18 Years -	Medical College of Wisconsin
Collection of Transplant Stem Cells for Plasma Cell Myeloma	NCT01547806	Plasma Cell Mye... Multiple Myelom...	Filgrastim Plerixafor Apheresis	18 Years - 75 Years	National Institutes of Health Clinical Center (CC)
Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer	NCT04478123	Multiple Myelom... Hodgkin Lymphom... Non-Hodgkin Lym... HDT-AHCT	Romiplostim	18 Years -	Memorial Sloan Kettering Cancer Center
Collection of Transplant Stem Cells for Plasma Cell Myeloma	NCT01547806	Plasma Cell Mye... Multiple Myelom...	Filgrastim Plerixafor Apheresis	18 Years - 75 Years	National Institutes of Health Clinical Center (CC)
ASCT for Relapsed APL After Molecular Remission	NCT00907582	Acute Promyeloc... Relapse	autologous hema...	18 Years - 60 Years	Shanghai Jiao Tong University School of Medicine
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia	NCT01050036	Leukemia, Myelo...	autologous hema...	15 Years - 65 Years	Asan Medical Center
Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma	NCT03224507	Multiple Myelom...	KRdD followed b... KRdD only	18 Years -	University of Alabama at Birmingham

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