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TERMINATED
NCT01421927
PHASE1

Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.

Official title: Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2011-08

Completion Date

2014-10

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

Lenalidomide

Start between Day+100 and Day+120 post-transplant \- Initial dose: 5 mg/day every day In the absence of thrombocytopenia \< 75000/mm3 or neutropenia \< 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day. \- Duration * until persistent stringent complete response for 3 months * or progression defined by IMWG criteria12 * or unacceptable toxicity * or one year after transplant

Locations (1)

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, France