Clinical trial · Interventional
Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma
Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): target number of inclusion not reached
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenalidomide
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Safety of lenalidomide
- timeFrame
- 1 year
- description
- The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide : * Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or * Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or * Transplant-related death
Secondary outcomes (8)
- measure
- One-year Progression-Free Survival
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available