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

NCT04024384 | Withdrawn Phase 2 DMC

• 1 other identifier: APHP180470
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Multiple Myeloma

Keywords

Myeloma

Outcome Measures

Primary Outcomes (1)

• safety and efficacy of Daratumumab assessed by free survival

  The primary objective is to assess the 1-year progression free survival in such patients. If the smallest response proportion (pnew=0.4) could be achieved compare to the lowest response probability of interest (phypo=0.2), the treatment strategy would worth to be developed further.

  1-year progression free survival in such patients

Secondary Outcomes (10)

• Disease response rate

  day +30, day +90 and 12 months after transplantation

• Overall survival

  12 months after transplantation

• GVHD-free

  12 months after transplantation

• Relapse-free survival

  12 months after transplantation

• Cumulative incidence of relapse, death from disease, and non-relapse mortality

  12 months after transplantation.

Study Arms (1)

Daratumumab

EXPERIMENTAL

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

Drug: Daratumumab

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).

Daratumumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'hématologie clinique et thérapie cellulaire

Paris, 75012, France

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rémy Dulery, PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 18, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 27, 2020

Record last verified: 2019-07

Locations

FR (1)