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Phase 2 Completed N=53 Treatment

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Source: ClinicalTrials.gov NCT00478218 ↗
Enrolled (actual)
53
Serious AEs
28.3%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment — 28; 16 participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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