Current Research: Medical Oncology

E1A06--Melphalan, Prednisone and Thalidomide (MPT) Vs Melphalan, Prednisone and Revlimid (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Melphalan, Prednisone and Thalidomide (MPT) is considered the gold standard therapy for myeloma patients not considered suitable for high dose Melphalan.

Lenalidomide is a new and active agent in multiple myeloma with very high response rates when used in combination with Dexamethasone. Lenalidomide (Revlimid) has similar single agent activity to thalidomide and a relative lack of major symptomatic toxicity (constipation, neuropathy, fatigue) when contrasted with thalidomide. Conversely, myelosuppression is more common, a finding that has made the combination of Lenalidomide with Melphalan and Prednisone (MPR) harder to tolerate and may result in dose reductions and compromised efficacy. Thus, which of these regimens will ultimately prove superior is not known.

Eligibility

You may be eligible for this trial if:

• Your multiple myeloma was symptomatic at time of initial diagnosis and has met the following criteria at one point in the disease course:
  • Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
  • Symptomatic disease at initial diagnosis that prompted initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
• You are older than 65 and have declined alternative treatment OR you are between 18 and 65 and not a candidate for autologous stem cell transplant in the treating physician’s opinion OR have declined transplant or other alternative treatment.
• You must be previously untreated for myeloma, although prior treatment for myeloma with prednisone or dexamethasone for < 4 wks total dosing alone or in combination with thalidomide or lenalidomide for < 2 wks total dosing IS allowable
• You must take prophylaxis with either 325 mg/day aspirin, or heparin or Coumadin

Trial Sponsor

• Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

• Mar 2009

Tentative Project End Date

• Aug 2010

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .