Status:
COMPLETED
Safety And Efficacy Of Lenalidomide As Maintenance Therapy In Patients With Newly Diagnosed Multiple Myeloma Following A Tandem Autologous-Allogeneic Transplant
Lead Sponsor:
Fondazione EMN Italy Onlus
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Rationale: We recently reported a study where overall and event free survivals in newly diagnosed myeloma patients receiving an autologous transplant followed by an allograft from an HLA-identical sib...
Detailed Description
A. Pre-transplant phase: Induction Therapy Patients will start induction treatment with lenalidomide and dexamethasone (RD) for 4 cycles every 28 days (as was detailed also in the GIMEMA protocol RV-...
Eligibility Criteria
Inclusion
- Newly diagnosed multiple myeloma patients with an HLA identical sibling suitable for PBSC donation and treated in induction with thalidomide or bortezomib or lenalidomide conteining regimes.
- Complete cytogenetic analysis at diagnosis, including FISH analysis for chromosome deletions 13 and 17, and translocations (4;14) (11;14) and (14;16).
- The patient must have the capacity to give informed consent.
- Age \>18 and \< 65
- If female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study
- If male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study
- Negative pregnancy test
Exclusion
- Karnofsky score less than 60 (see appendix C), unless due solely to myeloma
- Left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy
- Bilirubin greater than 2 X the upper limit of normal, or SGPT and SGOT \> 4 X the upper limit of normal
- DLCO \< 40% (corrected) or receiving continuous supplemental oxygen.
- Creatinine clearance \< 40 cc/min at the time of initial autografting evaluation.
- Patients with poorly controlled hypertension
- Patients with active non-hematologic malignancies (except non-melanoma skin cancers).
- Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \>20% risk of disease recurrence
- Seropositive for HIV
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
- To evaluate toxicity and tolerability of lenalidomide after allografting
- To evaluate efficacy of lenalidomide in inducing complete remission 12 months after allografting
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01264315
Start Date
September 1 2008
End Date
February 1 2023
Last Update
May 26 2023
Active Locations (1)
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1
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy, 10126