NCT00961467

RMPT for Relapsed/Refractory Multiple Myeloma

Lenalidomide, Melphalan, Prednisone, and Thalidomide (RMPT) for Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM) patients, without significant clinical benefit. After 40 years, the combination of MP with thalidomide (MPT) or lenalidomide (MPR) or bortezomib (MPV) have finally and consistently shown additive or synergistic effects.In advanced MM, the combination of melphalan, prednisone and thalidomide induced 12% very good partial response (VGPR) rate, while the combination of melphalan and bortezomib showed 15% near complete remission (nCR) rate. In relapsed patients, the combination of bortezomib with MPT (VMPT) induced 43% VGPR rate. Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed patients (unpublished results).In preclinical studies thalidomide showed more anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus suggesting a combined clinical approach for these two drugs. The toxicity profile of lenalidomide is completely different from that of thalidomide and no cumulative toxicities are expected, again suggesting a combination approach. This study will evaluate the safety and efficacy of combining Lenalidomide, Melphalan, Prednisone and Thalidomide (R-MPT) as salvage treatment for relapsed/refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MPT or MPR regimens.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Revlimid, Melphalan, Prednisone, Thalidomide	Thalidomide was administered at 50 mg/day.
DRUG	Revlimid, Melphalan, Prednisone, Thalidomide	Thalidomide was administered at 100 mg/day.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2016-04-01
• First posted: 2009-08-19
• Last updated: 2016-05-10

Locations

1 site across 1 country: Italy