A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
* 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
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
Duration of Treatment (up to 5 years)
Shaji K. Kumar, MD
United States: Food and Drug Administration
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|