Status:
WITHDRAWN
Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The present protocol aims to test, whether an approach using (i) a reduced-toxicity TBF followed by a (ii) Daratumumab maintenance and (iii) prophylactic infusion of donor lymphocytes (pDLI), will be ...
Detailed Description
Allogeneic stem cell transplantation in patients with multiple myeloma (MM) Outcomes for patients with MM who are resistant to proteasome inhibitors (bortezomib) and immunomodulatory drugs (lenalidomi...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of multiple myeloma
- Disease who progressed on salvage therapy or progressed within 60 days of the last treatment in patients who previously achieved at least a minimal response to treatment
- Stable disease or better 1 month before transplantation
- Age \> 18 and \< 70 years.
- Availability of an HLA-haploidentical or HLA-identical family donor
- Written informed consent.
Exclusion
- Presence in the patient of donor HLA-specific antibodies (DSA) directed against the HLA haplo-identical family donor
- Karnofsky score \<70%
- HIV positive patient, chronic or active Hepatitis B or Hepatitis C
- Life expectancy less than one month according to the attending physician
- Acute or chronic heart failure (Cardiac ejection fraction \< 40%)
- Pulmonary function - diffusion capacity \< 50% predicted
- Estimated glomerular filtration rate \< 30 ml/min (CKD-EPI)
- Severe neurological or psychiatric disorders
- Any circumstances that preclude the use of the drugs used within the protocol
- Prior allogeneic stem cell transplantation
- Pregnancy or denied of effective contraceptive method
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04024384
Start Date
July 1 2019
End Date
July 1 2024
Last Update
March 27 2020
Active Locations (1)
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1
Service d'hématologie clinique et thérapie cellulaire
Paris, France, 75012