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Trial record 24 of 122 for:    daratumumab multiple myeloma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02419118
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Vejle Hospital

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
Multiple Myeloma Drug: Daratumumab Drug: Lenalidomide Drug: Dexamethasone 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

Primary Outcome Measures :
  1. Response by IMWG criteria [ Time Frame: 4 weeks ]
    Assessed by M-component in blood and urine samples

Secondary Outcome Measures :
  1. T cell subset numbers [ Time Frame: 4 weeks ]
    Measured in bood and bone marrow aspirates

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT02419118

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Department of Hematology Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
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Principal Investigator: Torben Plesner, MD Vejle Hospital

Publications of Results:
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Responsible Party: Vejle Hospital Identifier: NCT02419118     History of Changes
Other Study ID Numbers: 181114
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Keywords provided by Vejle Hospital:
monoclonal antibody
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Antineoplastic Agents, Immunological
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents