Multiple Myeloma Clinical Trial
Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.
Full Description
OBJECTIVES:
Primary
Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma.
Determine the response rate in patients treated with this regimen. Secondary
Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study.
Phase I: Patients receive oral melphalan and oral prednisone daily on days 1-4. Patients also receive oral lenalidomide daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD. Patients also receive oral prednisone as in phase I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Newly diagnosed disease
Requires treatment, in the judgment of the treating physician
Not a candidate for (or patient declines) autologous stem cell transplantation
Meets 1 of the following criteria:
Measurable disease, defined by any of the following:
Serum monoclonal protein ≥ 1 g/dL
Urine protein monoclonal light chain ≥ 200 mg/24 hours by electrophoresis
Measurable serum free light chains ≥ 10 mg/dL, kappa or lambda, AND κ/λ ratio is abnormal (if serum and urine are not measurable as defined above)
Evaluable disease, defined as monoclonal bone marrow plasmacytosis ≥ 30%
PATIENT CHARACTERISTICS:
ECOG performance status 0-3
Life expectancy > 3 months
ANC ≥ 1,500/mm³
Bilirubin ≤ 2.0 mg/dL
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 3.0 mg/dL
Platelet count ≥ 100,000/mm³
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception, including ≥ 1 highly effective method, ≥ 4 weeks before and during study treatment
No uncontrolled infection
No peripheral neuropathy ≥ grade 2
No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance
No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
- Prior malignancy allowed if treated with curative intent and is free of disease for a period appropriate for that cancer
No known hypersensitivity to thalidomide
No known HIV positivity
No infectious hepatitis A, B or C
No history of deep vein thrombosis or other medical condition requiring the use of warfarin
Able to take daily prophylactic acetylsalicylic acid (81 or 325 mg)
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 4 weeks since prior radiotherapy for treatment of multiple myeloma
No prior lenalidomide
No other concurrent anticancer agents or treatments
No concurrent steroids except prednisone ≤ 20 mg/day (or the equivalent) for concurrent illness or adrenal replacement therapy
No other concurrent investigational therapy or agent for treatment of multiple myeloma
No concurrent warfarin
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There are 3 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Rochester Minnesota, 55905, United States
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