Overview

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

Status:
Withdrawn
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
All
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 able to improve progression-free survival of patients with refractory or relapsed MM. This trial represents the first prospective protocol aiming to test the use of Daratumumab maintenance after HLA-identical or haploidentical allo-SCT in patients with MM.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Antibodies, Monoclonal
Daratumumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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