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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: lenalidomide (Revlimid®); Drug: Cyclophosphamide; Drug: Prednisone

• Registration Number: NCT00540644
• Lead Sponsor: Attaya Suvannasankha

Brief Summary

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

Detailed 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..

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2012-12
• Study Completion: 2014-08
• Results First Submitted: 2016-04-05
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Results First Posted: 2016-06-21
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revlimid, Cyclophosphamide, Prednisone	lenalidomide (Revlimid®)	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.
Revlimid, Cyclophosphamide, Prednisone	Prednisone	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.
Revlimid, Cyclophosphamide, Prednisone	Cyclophosphamide	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.

Primary Outcome Measures

Name	Time	Method
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria	After 6 cycles	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Using the FACT-G Data	baseline and after last cycle (up to 6 cycles)	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
Treatment Related Adverse Events Grade 3 or Higher	Beginning of treatment up to 5 years	Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

Trial Locations

Locations (1)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States