Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple M… (NCT01421927) | Clinical Trial Compass
TerminatedPhase 1
Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma
Stopped: target number of inclusion not reached
France13 participantsStarted 2011-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.