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DARA: "Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

Sponsor
Vejle Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02419118
Collaborator
(none)
4
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

The effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified.

There is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. The integrity of the patient's immune system may be important. Prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. ADCC) effector mechanisms that are of importance for the response to daratumumab. Also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab.

A better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Present Status and Aspects of Effector Mechanisms With Emphasis on the CD38 Antibody Daratumumab "
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dara len dex

Daratumumab in combination with lenalidomide and dexamethasone

Drug: Daratumumab
Treatment of myeloma patients with Daratumumab
Other Names:
  • CD38 monoclonal antibody
  • HuMax CD38

    • Drug: Lenalidomide
    Treatment of myeloma patients

    Drug: Dexamethasone
    Treatment of myeloma patients
    Active Comparator: Len dex

    Lenalidomide in combination with dexamethasone

    Drug: Lenalidomide
    Treatment of myeloma patients

    Drug: Dexamethasone
    Treatment of myeloma patients

    Outcome Measures

    Primary Outcome Measures

    1. Response by IMWG criteria [4 weeks]

      Assessed by M-component in blood and urine samples

    Secondary Outcome Measures

    1. T cell subset numbers [4 weeks]

      Measured in bood and bone marrow aspirates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Accepted for a clinical trial with Daratumumab for myeloma
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hematology Vejle Hospital Vejle Denmark 7100

    Sponsors and Collaborators

    • Vejle Hospital

    Investigators

    • Principal Investigator: Torben Plesner, MD, Vejle Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vejle Hospital
    ClinicalTrials.gov Identifier:
    NCT02419118
    Other Study ID Numbers:
    • 181114
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Nov 7, 2017
    Last Verified:
    Nov 1, 2017
    Keywords provided by Vejle Hospital
    Myeloma
    monoclonal antibody
    Daratumumab
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone
    Lenalidomide
    Daratumumab

    Study Results

    No Results Posted as of Nov 7, 2017