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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Patients aged 18 to 65 years

• Multiple Myeloma in 2nd or 3rd complete or partial response*

• Disease never refractory to lenalidomide

• Lenalidomide treatment ≤ 9 months

• HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level)

• Insured under Social Security

• Information and consent signed

Exclusion Criteria:

• Stable or progressive disease

• Hypersensitivity to lenalidomide or excipients

• Lenalidomide treatment > 9 months

• Absence of efficient contraception in women or men

• Cardiac insufficiency (ejection fraction < 50% by echocardiography)

• Pulmonary disease characterized by DLCO < 60%

• Severe renal insufficiency (clearance of creatinin < 30 ml/min)

• Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin > 2 times the upper normal value except in case of Gilbert's disease

• Bacterial, Viral or Fungal uncontrolled infections

• No contraceptive method for Female subjects of childbearing potential

• No use of condoms for males subjects

• Pregnant or breast feeding woman

• History of previous cancer (other than myeloma) except if the patient is in complete remission for more than 5 years.