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• Status: Withdrawn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