Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments lenalidomide (revlimid®), cyclophosphamide, prednisone
Phase phase 2
Sponsor Indiana University School of Medicine
Collaborator Celgene Corporation
Start date October 2007
End date July 2013
Trial size 70 participants
Trial identifier NCT00540644, 0704-06; IUCRO-0170

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
lenalidomide (revlimid®) 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.

Primary Outcomes

Measure
Response Rate (RR) after 6 cycles of therapy using the proposed International Myeloma Working Group uniform response criteria
time frame: 6 cycles

Secondary Outcomes

Measure
The biologic effect of the RCP regimen on bone turnover markers.
time frame: baseline, 3 months, 6 months
The biologic effect of the RCP regimen on serum cytokine profiling
time frame: baseline, 3 months, 6 months
Safety (type, frequency, severity, and relationship of adverse events to study treatment)
time frame: assessed every 4 weeks
Quality of life using the FACT-G data
time frame: baseline, after 3 cycles, after 6 cycles

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria: - Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma PLUS one or more of the following: - Calcium elevation (11.5 mg/dl) [42.65 mmol/l] - Renal insufficiency (1.5 x the ULN of serum creatinine) - Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal) - Bone disease (lytic lesions or osteopenia) Measurable disease is defined at least one of the following three measurements: - Serum M-protein >=1 g/dl ( or 10 g/l) - Urine M-protein >=200 mg/24 h - Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal - Measurable plasmacytoma - NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response. Laboratory test results within these ranges: - Absolute neutrophil count >= 1.0 x 109/L - Platelet count >= 50 x 10(9)/L - Hemoglobin >= 9 gm/dl - Serum creatinine <= 2.5mg/dL. - Total bilirubin <=1.5 x upper limit of normal - AST (SGOT) and ALT (SGPT) <= 3 x ULN Exclusion Criteria: - Known hypersensitivity to thalidomide - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. - Patients with a solitary plasmacytoma - Patients with uncontrolled diabetes - Patients with ≥ Grade 3 sensory neuropathy - History of cardiac disease, with NYHA Class II or greater

Additional Information

Official title Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
Principal investigator Attaya Suvannasankha, M.D.
Description 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..
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Indiana University.