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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04024384
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab, 16 mg/kg, once a week for 8 weeks (cycles 1 and 2); then every 2 weeks for 16 weeks (cycles 3-6), then every 4 weeks thereafter (cycles 7-12).

Study Details

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.

Key Dates

First listed
Jul 18, 2019
Start date
Jul 31, 2019
Status verified
Jul 2019
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    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

Primary Outcome Measure

safety and efficacy of Daratumumab assessed by free survival [ Time Frame: 1-year progression free survival in such patients ]

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