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Trial record 4 of 123 for:    daratumumab multiple myeloma

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 (DARALLO)

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ClinicalTrials.gov Identifier: NCT04024384
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
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
Drug: Daratumumab
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).




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


Secondary Outcome Measures :
  1. Disease response rate [ Time Frame: day +30, day +90 and 12 months after transplantation ]
    Disease response rate at day +30, day +90 and 12 months after transplantation

  2. Overall survival [ Time Frame: 12 months after transplantation ]
    Overall survival, at 12 months after transplantation

  3. GVHD-free [ Time Frame: 12 months after transplantation ]
    GVHD-free, at 12 months after transplantation

  4. Relapse-free survival [ Time Frame: 12 months after transplantation ]
    Relapse-free survival at 12 months after transplantation

  5. Cumulative incidence of relapse, death from disease, and non-relapse mortality [ Time Frame: 12 months after transplantation. ]
    Cumulative incidence of relapse, death from disease, and non-relapse mortality within the first 12 months after transplantation.

  6. Cumulative incidence of chronic GVHD as assessed by NIH Consensus Criteria [ Time Frame: 12 months after transplantation. ]
    Cumulative incidence of chronic GVHD as assessed by NIH Consensus Criteria within the first 12 months after transplantation.

  7. Serious adverse events of Daratumumab and number of infusion per patient [ Time Frame: 12 months after transplantation. ]
    Serious adverse events of Daratumumab and number of infusion per patient

  8. Serious adverse events of prophylactic donor lymphocytes infusion (pDLI) and number of infusion per patient [ Time Frame: 12 months after transplantation. ]
    Serious adverse events of prophylactic donor lymphocytes infusion (pDLI) and number of infusion per patient

  9. Quality of Life [ Time Frame: at day-7, +30, +90, +180 and +360 ]
    Quality of Life at day-7, +30, +90, +180 and +360

  10. immune response analysis [ Time Frame: (before transplant, 30 days after transplant, 1 year after transplant and in case of disease relapse) ]
    immune response analysis (before transplant, 30 days after transplant, 1 year after transplant and in case of disease relapse)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024384


Contacts
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Contact: Rémy DULERY, PHD +33 149 28 26 20 remy.dulery@aphp.fr
Contact: Mohamad Mohty, PHD +33 149 28 26 20 mohamad.mohty@inserm.fr

Locations
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France
Service d'hématologie clinique et thérapie cellulaire Not yet recruiting
Paris, France, 75012
Contact: Rémy Dulery, PHD    +33 149 28 26 20    remy.dulery@aphp.fr   
Contact: Mohamad Mohty    +33 149 28 26 20    mohamad.mohty@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Rémy Dulery, PHD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04024384     History of Changes
Other Study ID Numbers: APHP180470
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Daratumumab
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs