Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Prednisone

Lenalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Prednisone every other day orally.

25 mg p.o. daily on days 1-21 of each 28 day cycle

lenalidomide (Revlimid®)

50 mg p.o. BID daily on days 1-21 of each 28 day cycle

Attaya Suvannasankha, M.D.

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma

Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.

Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.

Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome

Celgene

Attaya Suvannasankha

Assistant Professor of Medicine

Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Original Study - Revlimid, Cyclophosphamide, Prednisone

Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Extension - Revlimid, Cyclophosphamide, Prednisone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Attaya Suvannasankha

All patients receiving at least one dose of study drug and having at least one post-baseline visit

Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria

All patients enrolled and received treatment.

Treatment Related Adverse Events Grade 3 or Higher

Physical Well-Being Change from Baseline

Social/Family Well-Being Change from Baseline

Emotional Well-Beling Change from Baseline

Functional Well-Being Change from Baseline

FACT-G Change from Baseline

All patients enrolled and received treatment with a baseline and post-baseline measurement.

Quality of Life Using the FACT-G Data

Overall Study

Spots Global Cancer Trial Database for Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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