Back to resultsPhase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lenalidomide (Revlimid®)
Cyclophosphamide
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Revlimid
Eligibility Criteria
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
Sites / Locations
- Indiana University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Revlimid, Cyclophosphamide, Prednisone
Arm Description
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.
Outcomes
Primary Outcome Measures
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
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
Treatment Related Adverse Events Grade 3 or Higher
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Quality of Life Using the FACT-G Data
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
Full Information
NCT ID
NCT00540644
First Posted
October 5, 2007
Last Updated
May 12, 2016
Sponsor
Attaya Suvannasankha
Collaborators
Celgene
1. Study Identification
Unique Protocol Identification Number
NCT00540644
Brief Title
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Official Title
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Attaya Suvannasankha
Collaborators
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Revlimid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Revlimid, Cyclophosphamide, Prednisone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lenalidomide (Revlimid®)
Other Intervention Name(s)
Revlimid®
Intervention Description
25 mg p.o. daily on days 1-21 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
50 mg p.o. Q.O.D.
Primary Outcome Measure Information:
Title
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Description
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.
Time Frame
After 6 cycles
Secondary Outcome Measure Information:
Title
Treatment Related Adverse Events Grade 3 or Higher
Description
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Time Frame
Beginning of treatment up to 5 years
Title
Quality of Life Using the FACT-G Data
Description
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
Time Frame
baseline and after last cycle (up to 6 cycles)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attaya Suvannasankha, M.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
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