Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00478218|
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : July 27, 2011
Last Update Posted : August 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: cyclophosphamide Drug: dexamethasone Drug: lenalidomide||Phase 2|
* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.
- Assess the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||April 2011|
300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
Other Name: Cytoxan, CTX, Neosar®Drug: dexamethasone
40 mg administrated by PO (with food)on Days 1, 8, 15 & 22
Other Name: DecadronDrug: lenalidomide
25 mg administrated by PO (with food)on Days 1-21
Other Name: Revlimid®
- Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment [ Time Frame: Duration of Treatment (up to 5 years) ]
Response that was confirmed on 2 consecutive evaluations during treatment
- Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
- Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
- Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
- Overall Survival (OS) [ Time Frame: up to 5 years ]OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
- Progression-free Survival (PFS) [ Time Frame: up to 5 years ]
PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.
Progression was defined as any one or more of the following:
An increase of 25% from lowest confirmed response in:
- Serum M-component (absolute increase >= 0.5g/dl)
- Urine M-component (absolute increase >= 200mg/24hour
- Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
- Bone marrow plasma cell percentage (absolute increase of >=10%)
- Duration of Response (DOR) [ Time Frame: up to 5 years ]Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478218
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Shaji K. Kumar, MD||Mayo Clinic|
|Principal Investigator:||Craig B. Reeder, MD||Mayo Clinic|