Status:
COMPLETED
Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 eff...
Detailed Description
Lenalidomide has a significant clinical activity in patients with relapsed or refractory MM and in patients relapsing after Allo-SCT. The mechanisms of action involve immunomodulation, anti-angiogenes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01421927
Start Date
August 1 2011
End Date
October 1 2014
Last Update
July 23 2015
Active Locations (1)
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1
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33600