Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00478218
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
- Detailed Description
OBJECTIVES:
Primary
\* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide/Cyclophosphamide/Dexamethasone cyclophosphamide - Lenalidomide/Cyclophosphamide/Dexamethasone dexamethasone - Lenalidomide/Cyclophosphamide/Dexamethasone lenalidomide -
- Primary Outcome Measures
Name Time Method Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment 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
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 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) 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) 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.
Trial Locations
- Locations (2)
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States