Phase 2
N=53
Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00478218 ↗Enrolled (actual)
53
Serious AEs
28.3%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment — 28; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); dexamethasone (Drug); lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment |
28; 16 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) |
27; NA | — |
| SECONDARY Duration of Response (DOR) |
26.1; NA | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Newly diagnosed disease
- Symptomatic disease
- Measurable or evaluable disease, defined by ≥ 1 of the following criteria:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- Monoclonal protein > 200 mg by 24-hour urine electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
- Measurable soft tissue plasmacytoma not previously irradiated
- No monoclonal gammopathy of undetermined significance or smoldering myeloma
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Creatinine ≤ 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy
- No uncontrolled infection
- No other active malignancy
- No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- No NYHA class III-IV congestive heart failure
- No untreated active deep vein thrombosis
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy for solitary plasmacytoma
- Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed
- No prior cytotoxic chemotherapy
- No prior corticosteroids (except for treatment of a nonmalignant disorder)
- Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed
- No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture
Data sourced from ClinicalTrials.gov (NCT00478218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.