Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients With Overall Confirmed Response
Response that was confirmed on 2 consecutive evaluations. Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow Very Good Parital Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells
Every cycle during treatment
Vivek Roy, MD, FACP
United States: Food and Drug Administration
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