Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

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Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hepatitis A

Hepatitis

Hepatitis B

Paraproteinemias

Liver Diseases

Gastrointestinal Diseases

Communicable Diseases

Blood-Borne Infections

Hepadnaviridae Infections

Virus Diseases

DNA Virus Infections

Hepatitis, Viral, Human

Blood Protein Disorders

Hematologic Diseases

Immunoproliferative Disorders

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Placebo

Nikhil C Munshi, M.D.

This is a research study to determine if the study drug lenalidomide will increase the body's immune response, which is the body's response against infections or tumors, to hepatitis B vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It is not a study to see if lenalidomide is an effective treatment for plasma cell disease.

Participants in this study have multiple myeloma or other plasma cell disease and have never been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to alter the immune system and thereby increase immune response. It also has some effect against cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer cells.

In this study, one-half of the subjects will be chosen at random to receive the study drug and the other half will take a placebo pill (a sugar pill that looks the same as the real medication). This is a double blind study where neither the subjects nor the investigators know whether the patient receives the study drugs or placebo pills. The effects of the active drug lenalidomide will be compared to the effects of the placebo. The results from this study will be also be compared with a similar but separate study to be done on individuals without known disease.

This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare System and the Dana Farber Cancer Institute.

The primary object of this study is to evaluate the effect of CC-5013 on the response to hepatitis B vaccine in myeloma. Secondary objectives include the evaluation of immunologic and functional genomic changes following CC-55013.

This study will be a two-center, randomized, double-blinded, placebo-controlled trial. A single dose of Hepatitis B vaccine will be administered to subjects. CC-5013 or placebo will be administered for 7 days prior to and 7 days after the vaccine. Collection of samples for immune analysis will be performed prior to the initiation of CC-5013 administration, at the time of vaccination, and 7, 14, and 28 days after vaccination. Safety assessment will be performed at each visit.

Primary Endpoint

* Titer of antibodies to hepatitis B virus Secondary Endpoints
* Immune analysis
* Hepatitis B related T cell response
* Safety profile

All the patients should not have a prior response against hepatitis B surface antigen. The study will be comprised of 64 multiple myeloma patients who have not taken any therapeutic agents in the 30 days prior to enrollment in the study. Subjects will be randomly assigned to receive or not receive CC-5013, and all will be vaccinated. The study is designed to detect a biological difference of 50% with an alpha of 0.05 and a beta of 0.8.

Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias

Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias

The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

Number of participants with adverse events as a measure of safety and tolerability

Participants who displayed a T cell responses against HbSAg following vaccination

Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.

Dana-Farber Cancer Institute

Boston VA Research Institute, Inc.

Associate Professor of Medicine Harvard Medical School; Physician

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Nikhil C. Munshi

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.

Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.

Placebo will be administered for 7 days prior to and 7 days after the vaccine.

Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine.

Positive for Hepatitis B Surface Antigen

Safety

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Quantity of Subjects With a T-cell Response

Total T cells CD3+

Helper T cells CD3+/CD4+

Cytotoxic T cells CD3+/CD8+

Natural Killer cells CD56+/CD16+

Phenotypic Changes

Overall Study

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Myeloproliferative Disorders

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunomodulating Agents

Lenograstim

Mycophenolic Acid

Tacrolimus

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant

14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)

Total Body Irradiation

1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.

dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.

cellcept

5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days.

g-csf

cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight

Peripheral Blood Transplant

Kenneth Meehan, MD

The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.

We propose a clinical trial to define clinical endpoints, including engraftment, 100-day survival and one year survival (Objective #1). We will characterize the incidence, prevalence and function of immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). We will correlate these laboratory results with clinical outcomes and the incidence of GVHD. As an exploratory aim, in those patients experiencing GVHD and requiring treatment, we will define the frequency/expression of checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression

To characterize the incidence of immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation, cytotoxic T-lymphocyte-associated protein 4 \[CTLA\], Programmed cell death protein 1 \[PD-1\]) during early immune recovery following an allogeneic stem cell transplant.

In those patients experiencing GVHD, the study team will define the checkpoint regulator expression on MDSCs

In those patients experiencing GVHD, the study team will define the peripheral blood mononuclear cells and myeloid subsets.

In those patients experiencing GVHD, the study team will define the myeloid subsets.

In those patients experiencing GVHD, the study team will define the MDSCs frequency.

To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.

Flow cytometry will be used to characterize the function of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.

Dartmouth-Hitchcock Medical Center

Principal Investogator- Kenneth Meehan, MD Staff Physician

Group randomized to participate in Tai Chi intervention

Group randomized to participate in educational intervention

Tai Chi

Education

Nandita Khera, MD, MPH

Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation?

All patients with Multiple Myeloma seen at Mayo Clinic Arizona who are undergoing evaluation for autologous stem cell transplant will be identified for potential candidacy by BMT transplant coordinator staff and referred to CRC study staff for final screen of candidacy over a period of 12 months. If eligible, ≤ 30 days prior to transplant CRC study staff will meet with patient for consent and undergo 1:1 randomization to Tai Chi versus educational control arm (N: 70). No earlier than 7 days prior to transplant all patients will attend a 1 hour session consisting of Tai Chi techniques or receive educational materials depending on the patients prior randomization and will start their intervention, subject diary and support materials will be provided. Patients will be asked to perform 30 minutes of intervention daily (Tai Chi versus educational control) and document minutes and quality of practice in their subject diary. On day 1 of autologous stem cell transplant CRC staff will administer the baseline questionnaires (NIH PROMIS Short form questionnaires for pain, depression, anxiety, social isolation, and sleep). Patients will continue their intervention (Tai chi versus educational control) daily throughout autologous stem cell transplant and record intervention fidelity in patient diary. On day 14 of transplant the NIH PROMIS questionnaires, perceived benefit questionnaire, and the meditative movement inventory for the Tai chi group only will be collected. Data collection for secondary outcomes including time to engraftment, incidence of febrile neutropenia, days of hospitalization, etc will be also gathered. Patients will continue intervention through transplant day 30 (+/- 5 days) at which time, CRC staff will collect subject diary, administer NIH PROMIS questionnaires, and a perceived benefit questionnaire. Adherence reminders will be executed once per week by CRC staff from date of initiation of intervention to completion of study.

The intervention to be tested, TCEasy, is a standardized protocol that was developed by Dr. Roger Jahnke and has been used in several prior studies including a recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors (U01 AT002706-03: PI Linda Larkey, PhD, Arizona State University, primary outcome paper currently under review). Participants will be given a written instruction manual for the Tai Chi exercises to refer to after training has been administered.

Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias	NCT02041325	Plasma Cell Dis...	Lenalidomide Placebo	18 Years -	Boston VA Research Institute, Inc.
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression	NCT03480360	Acute Myeloid L... Chronic Lymphoc... Chronic Myeloid... Myelodysplasia Myeloproliferat... Myelofibrosis Lymphoma Lymphoma, Non-H... Plasma Cell Dis...	Cyclophosphamid... Fludarabine Total Body Irra... Tacrolimus cellcept g-csf Peripheral Bloo...	18 Years - 75 Years	Dartmouth-Hitchcock Medical Center
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma	NCT02274519	Multiple Myelom... Plasma Cell Dis...	Tai Chi Education	18 Years -	Mayo Clinic

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