A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
Outcome Description:
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
Outcome Time Frame:
Duration of Treatment (up to 5 years)
Safety Issue:
No
Principal Investigator
Shaji K. Kumar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000546657
NCT ID:
NCT00478218
Start Date:
July 2006
Completion Date:
April 2011
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
