Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT00961467
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2009-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RMPT for Relapsed/Refractory Multiple Myeloma
Sponsor:
Fondazione EMN Italy Onlus
Organization:
Study Overview
Official Title:
Lenalidomide, Melphalan, Prednisone, and Thalidomide (RMPT) for Relapsed/Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMPT
Brief 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 Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed patients (unpublished results).In preclinical studies thalidomide showed more anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus suggesting a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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: