Neoplasms

Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Immune System Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Multiple Myeloma

Neoplasms, Plasma Cell

Amyloidosis

Polyneuropathies

Monoclonal Gammopathy of Undetermined Significance

Smoldering Multiple Myeloma

Glomerulonephritis, Membranous

Leukemia, Plasma Cell

Endocrine System Diseases

POEMS Syndrome

Castleman Disease

Cryoglobulinemia

Syndrome

Paraproteinemias

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Proteostasis Deficiencies

Metabolic Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Hypergammaglobulinemia

Precancerous Conditions

Lymphatic Diseases

Skin Diseases

Skin Diseases, Vascular

Congenital Abnormalities

Abnormalities, Multiple

Membranous Nephropathy

Plasma Cell Leukemia

Unicentric Castleman Disease

Light Chain Deposition Disease

No intervention

Bo Tang, PhD

Yujun Dong, M.D.

Yangliu Li

The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.

Primary

1. To establish a prospective cohort of patients with PCDs in PKUFH.
2. To dynamically analyze the relation between MRD status and prognosis, and the possible role of TME in PCD patients.

Secondary To collect peripheral blood, bone marrow aspirate and urine samples from PCD patients for future study, such as the tumor clone selection and evolution.

OUTLINE: PCD patients enrolled in this study will be assessed at baseline, clinical and laboratory data and biological samples be collected. Follow-up will be done at the 1, 3, 6, 12 months and then yearly after treatment.

Peripheral blood, bone marrow aspirate and urine samples will be banked for future research involving adults with PCDs.

A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH

A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH

To measure the treatment response in the cohort study of PCDs in PKUFH.The treatment response is done according to the criteria of the International Myeloma Working Group (IWMG) of 2016.

Peking University First Hospital

chief of department of hematology

Amy Garrett, MA

Kirsten Nyrop, PhD

Sascha Tuchman, MD

The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a "geriatric assessment," as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).

OBJECTIVES:

Primary

1. To create a Registry (to be called the PCD Registry) of PCD patients
2. To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time.

Secondary

1. To gather information, including patterns of patient care, that would lend support for future research in the PCD population. Specific research questions would be explored within separate IRB-reviewed protocols.
2. To bank blood samples for future research involving adults with PCD's, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-approved protocols as specific research questions are identified.

OUTLINE: Patients complete an assessment at baseline and then longitudinally over time which involves a multi-dimensional inter-disciplinary evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed.

Blood samples will be banked for future research involving adults with PCDs, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-reviewed protocols as specific research questions are identified.

Registry for Adults With Plasma Cell Disorders (PCD's)

Including patterns of patient care that would lend support for future research in patients with confirmed PCD's.

Done by measuring:

* percentage of patients contacted who consent to complete the assessment percentage of patients able to complete the self-administered portion of the assessment without assistance
* the length of time necessary to complete the assessment
* the variance and number of missing items
* the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memor Concentration Test, and the healthcare professional-rated Karnofsky performance status.

UNC Lineberger Comprehensive Cancer Center

Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Inflammatory Breast Cancer

CX-4945 Capsules, Oral, Dose escalation study, Dose schedule: twice daily or four times daily for 21 consecutive days every 28 days.

CX-4945 oral formulation

Clinical Trials Office Mayo Clinic Cancer Center

Donald Northfelt, MD

P. Zeller

Robert F Marschke, MD

Pat Zeller

R. McFarland, MD

R. Alvarez, MD

Study Director

This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma.

Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer. CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects of CX-4945 administered to patients with malignancies or lymphoproliferative disorders known to overexpress CK2 including advanced solid tumors, Multiple Myeloma and Castleman's Disease.

Dose-escalation Study of Oral CX-4945

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Advanced Solid Tumors, Castleman's Disease or Multiple Myeloma

Cylene Pharmaceuticals

Infections

Herpes Simplex

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sarcoma

Virus Diseases

Sarcoma, Kaposi

Communicable Diseases

Neoplasms, Connective and Soft Tissue

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Slow Virus Diseases

Genital Diseases

Urogenital Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease

Irene Ekwede, R.N.

Robert Yarchoan, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

A person s genome is the collection of all their genes. A gene instructs individual cells to make proteins. Proteins are involved in all of our body s chemical processes. Genome sequencing allows researchers to find variations in genes. Some of these are normal and are not known to cause disease. Some variants are known to cause or affect diseases like cancer. Researchers want to study genetic variants in people with cancer who also have an immunologic disease like HIV.

Objective:

To study the biology of cancer in order to improve ways to prevent, detect, and treat it.

Eligibility:

Adults at least 18 years old with certain cancers and/or immunodeficiencies

Design:

Participants will be screened with medical history, physical exam, and lab tests.

Participants will give samples of one or more tissue type.

They may give blood or urine samples.

Researchers may get samples of tissue when participants have surgery or when the participants are on other protocols in the NCI.

Participants may have a procedure to have tissue samples removed.

Researchers may collect data from participant medical records.

Researchers will compare the genes in a participant s cancer tissue to their normal tissue. They may use the tissue cells to grow new cells in a lab.

Participants may be contacted about the results.

The samples will be stored for future research. No personal data will be kept with them.

...

Background:

* The availability of high quality, clinically annotated patient samples is crucial for the study of biologic factors that influence the natural history of viral related malignancies, malignancies occurring in the setting of HIV, and Castleman disease.
* Comprehensive genomic sequence of viral-associated malignancies, malignancies occurring in the setting of HIV, tumors hypothesized to be caused by endogenous retroviruses, and Castleman disease may identify diagnostic or prognostic disease signatures, and recurrent driver alterations that interact with viral factors, and may identify targets for new therapies.
* Comparison of transcriptomes and genomes between cancers or Castleman disease from HIV+ and HIV- individuals might identify novel non-human sequences that could potentially suggest the presence of transcripts from hitherto undiscovered oncogenic viral agents.

Objective:

-The primary objective of this protocol is to support molecular investigation of viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated tissue from such participants as well as participants with tumors that may serve as appropriate controls.

Eligibility:

* Age \>=18 years
* HIV or other acquired immunodeficiency and cancer or
* Viral-associated cancer or
* HIV-negative with cancer that commonly occurs in people with HIV or
* Kaposi sarcoma herpes virus (KSHV)-associated malignancy or related diseases, such as Multicentric Castleman Disease or
* Idiopathic Castleman disease or
* Tumors that are hypothesized to be caused by endogenous retroviruses

Design:

* Samples will be processed using project specific collection and processing protocols.
* Collection of non-tumor specimens will generally be performed to obtain germ-line genetic material. The results between tumor and normal DNA will be analyzed to identify the somatic changes present in the cancer tissues.
* Alterations to be evaluated may include: detection of chromosomal changes, such as, but not limited to, amplification, deletions, loss of heterozygosity, translocations, etc.; as well as expression profiling and detection of transcripts resulting from translocations and mutations, including single nucleotide variants, insertions, deletions, etc.
* Multiple forms of project specific analyses may be performed, including evaluation of polymorphisms, mutations, gene expression, circulatory and tissue-based biomarkers, whole exome sequencing, and clinical pathologic correlation based on project specific statistical and bioinformatics plans.
* Alterations may also be analyzed within the context of biological pathways and systems biology being evaluated in a given project.

Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease

National Cancer Institute (NCI)

Lymphoma

Lymphoma, Non-Hodgkin

Lymphadenopathy

Hyperplasia

Lymphoma, B-Cell

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunoglobulins

Siltuximab

Patients will receive 4 administrations of 3 mg/kg CNTO 328 every 2 weeks till Day 43.

Patients will receive 4 administrations of 6 mg/kg CNTO 328 every 2 weeks till Day 43.

Patients will receive 3 administrations of 12 mg/kg CNTO 328 every 2 weeks till Day 43.

Patients will receive 7 administrations of 6 mg/kg CNTO 328 every week till Day 43.

Patients will receive 4 administrations of 12 mg/kg CNTO 328 every 2 weeks till Day 43.

Patients will receive 3 administrations of 12 mg/kg CNTO 328 every 3 weeks till Day 43.

Patients responding to CNTO 328 treatment will receive 9 mg/kg CNTO 328 every 3 weeks.

Patients responding to CNTO 328 treatment will receive 12 mg/kg CNTO 328 every 3 weeks as extended administration.

Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks.

CNTO 328

Centocor, Inc. Clinical Trial

The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma or Castleman's disease.

This research study will use a type of drug called anti-IL-6 antibody, also known as CNTO 328. An antibody is a substance in the body that fights infection. CNTO 328 is an investigational drug that has been shown to slow down tumor growth or shrink tumors when tested in animals. In a previous clinical trial in patients with multiple myeloma (blood cancer), CNTO 328 appeared to be a potent inhibitor of IL-6 . One study has been completed for kidney cancer. There are studies ongoing in humans with multiple myeloma and prostate cancer to see if CNTO 328 is safe and to see what effects it has on these types of cancer. This is an open-label, nonrandomized, dose-finding phase 1 study with CNTO 328 in patients with B- cell non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's disease. The purpose of this study is to evaluate different doses and schedules of CNTO 328 to see which dose/schedule is safe. CNTO 328 will be given through a small tube that goes directly into your vein, called an intravenous (IV) infusion. Depending on when the patient enters the study, the patient will be assigned to receive one course of CNTO 328 in one of the following groups: Group 1: 3 mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 2: 6 mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 3: 12 mg/kg 2 hr IV infusion every 3 weeks for 3 doses. Group 4: 6 mg/kg 2 hr IV infusion every week for 7 doses. Group 5: 12 mg/kg 2 hr IV infusion every 2 weeks for 4 doses. Group 6: 12 mg/kg 1 hr IV infusion every 3 weeks for 3 doses. Group 7a: 9 mg/kg 1 hr IV infusion every 3 weeks. Group 7b: 12 mg/kg 1hr IV infusion every 3 weeks for Castleman's patients only. In Groups 1-5, the overall amount of study drug that will be given increases with each higher group. Group 1 will be filled before Group 2 starts and Group 2 will be filled before Group 3 starts, etc. In this way, CNTO 328 can be tested more safely. Both the patient and the study doctor will know to which group the patient is assigned. Patients will remain in the group that they are assigned to for the entire time of participation in the study. Up to 70 patients may take part in this study. Patients in Groups 1-6 will be in the study for up to 34 weeks prior to Post Study Follow-Up. Screening: up to 4 weeks before the first dose schedule of CNTO 328. Treatment: up to 6 weeks of treatment with CNTO 328. Extended Dosing: Patients assigned to Groups 1-6, and their cancer or disease has become stable or better while receiving CNTO 328, may be able to receive additional courses of study drug. Patients in Group 7 will be in the study until their disease gets worse, they can no longer tolerate CNTO 328, the study doctor feels it is in their best interest to stop CNTO 328 or they longer wish to participate in the study. Long Term Follow-Up: Patients will be contacted by telephone every six months after the last infusion of study drug to assess the patient's disease status and survival. Dose (6-12 mg/kg) and frequency (weekly or 2 or 3 week intervals) of dosing depends upon Group assignment. CNTO 328 will be given through a small tube that goes directly into your vein, called an intravenous (IV) infusion. The infusion will take about 2 hours to complete for groups 1-5 and 1 hour for Groups 6 and 7. In Groups 1-6, CNTO 328 will be given once every 1, 2 or 3 weeks from days 1 to 43 depending on treatment assignment. In Group 7a and Group 7b, CNTO 328 will be given on day 1 of each 21 day cycle.

A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

Number of Patients with adverse events will be reported.

Serum Concentration of CNTO 328 will be reported.

Pharmacodynamic parameters C-reactive protein, interleukin-6 (IL-6), soluble IL-6 receptor \[GP80\], soluble GP130, TNFα, ΙL-8, IL-10, soluble IL-2 receptor (sIL-2R), IFNγ, serum amyloid A (SAA), N-telopeptide (NTx), C-telopeptide (CTx), hepcidin-25, VEGF, and fibroblast growth factor will be assessed.

Plasma antibodies to CNTO 328 will be used to evaluate the immunogenicity of CNTO 328.

Evaluation of tumor response for subjects with Castleman's disease were performed by central review according to the standard criteria, developed by an NCI-sponsored international working group (Cheson et al, 1999).

Evaluation of disease response for subjects with Multiple Myeloma were performed by the investigators according to the response criteria developed by an international group of multiple myeloma and bone marrow transplant experts (Blade et al, 1998).

CB will assess pain (by Pain intensity \[PI\] and 7-items assessing how much pain interfered with daily activities), performance status (by Karnofsky performance status which quantifies participant's well-being and activities of daily life), and weight change. PI score will be assessed by 4 questions (Q) rated on 11-point numerical rating scale ranging from "0=no pain" to "10=higher severity of pain". Each participant will be classified as either CB responder (i.e., if +ve for at least 1 of 3 primary CB measures and stable for other 2) or Non-responder (If a participant is stable on all 3 primary measures OR if -ve for any 1 of 3 primary measures).

CB assessments for participant with Castleman's disease consist of the following 6 measures: hemoglobin, fatigue, anorexia, fever, weight, and size of largest lymph node. Each participant will be classified as either improved, stable, or worsening for each of the measures. If a participant has improved for at least 1 of the 6 measures and is at least stable for the remaining measures, participant will be considered to be a responder for CB. If a participant has worsening for at least 1 of the 6 measures, participant will be considered as having progression for CB. Any other participant will be considered to be stable for CB. Any "improved" or "stable" assessment of the lymph node parameter for CB must be confirmed by radiographic imaging. If a participant shows progression for CB at 2 consecutive assessments the participant must discontinue study treatment.

Evaluation of disease response for subjects with B-cell non-Hodgkin's lymphoma were performed by the investigators according to the standard criteria, developed by an NCI-sponsored international working group (Cheson et al, 1999).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH	NCT05283993	Multiple Myelom... Amyloidosis Cryoglobulinemi... Castleman's Dis... Light Chain Dep... Heavy Chain Dep... Polyneuropathy ... Smoldering Mult... Plasma Cell Leu... Monoclonal Gamm... Monoclonal Gamm... Monoclonal Gamm...	No intervention	-	Peking University First Hospital
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH	NCT05283993	Multiple Myelom... Amyloidosis Cryoglobulinemi... Castleman's Dis... Light Chain Dep... Heavy Chain Dep... Polyneuropathy ... Smoldering Mult... Plasma Cell Leu... Monoclonal Gamm... Monoclonal Gamm... Monoclonal Gamm...	No intervention	-	Peking University First Hospital
Registry for Adults With Plasma Cell Disorders (PCD's)	NCT03717844	Multiple Myelom... Amyloidosis Cryoglobulinemi... Castleman's Dis... Light Chain Dep... Heavy Chain Dep... Polyneuropathy ... Smoldering Mult... Plasma Cell Leu...		18 Years -	UNC Lineberger Comprehensive Cancer Center
Dose-escalation Study of Oral CX-4945	NCT00891280	Advanced Solid ... Breast Cancer Inflammatory Br... Castleman's Dis... Multiple Myelom...	CX-4945 oral fo...	18 Years -	Cylene Pharmaceuticals
Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease	NCT03300830	Human Immunodef... Castleman's Dis... Kaposi's Sarcom... Viral-Associate...		18 Years -	National Institutes of Health Clinical Center (CC)
A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease	NCT00412321	Lymphoma, Non-H... Multiple Myelom... Giant Lymph Nod...	CNTO 328	18 Years -	Centocor, Inc.
Registry for Adults With Plasma Cell Disorders (PCD's)	NCT03717844	Multiple Myelom... Amyloidosis Cryoglobulinemi... Castleman's Dis... Light Chain Dep... Heavy Chain Dep... Polyneuropathy ... Smoldering Mult... Plasma Cell Leu...		18 Years -	UNC Lineberger Comprehensive Cancer Center
Dose-escalation Study of Oral CX-4945	NCT00891280	Advanced Solid ... Breast Cancer Inflammatory Br... Castleman's Dis... Multiple Myelom...	CX-4945 oral fo...	18 Years -	Cylene Pharmaceuticals

Spots Global Cancer Trial Database for castleman's disease