Back to results"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab " (DARA)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Daratumumab
Lenalidomide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, monoclonal antibody, Daratumumab
Eligibility Criteria
Inclusion Criteria:
- Accepted for a clinical trial with Daratumumab for myeloma
Exclusion Criteria:
- None
Sites / Locations
- Department of Hematology Vejle Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dara len dex
Len dex
Arm Description
Daratumumab in combination with lenalidomide and dexamethasone
Lenalidomide in combination with dexamethasone
Outcomes
Primary Outcome Measures
Response by IMWG criteria
Assessed by M-component in blood and urine samples
Secondary Outcome Measures
T cell subset numbers
Measured in bood and bone marrow aspirates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419118
Brief Title
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "
Acronym
DARA
Official Title
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Present Status and Aspects of Effector Mechanisms With Emphasis on the CD38 Antibody Daratumumab "
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
October 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, monoclonal antibody, Daratumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dara len dex
Arm Type
Experimental
Arm Description
Daratumumab in combination with lenalidomide and dexamethasone
Arm Title
Len dex
Arm Type
Active Comparator
Arm Description
Lenalidomide in combination with dexamethasone
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
CD38 monoclonal antibody, HuMax CD38
Intervention Description
Treatment of myeloma patients with Daratumumab
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Treatment of myeloma patients
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Treatment of myeloma patients
Primary Outcome Measure Information:
Title
Response by IMWG criteria
Description
Assessed by M-component in blood and urine samples
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
T cell subset numbers
Description
Measured in bood and bone marrow aspirates
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Accepted for a clinical trial with Daratumumab for myeloma
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Plesner, MD
Organizational Affiliation
Vejle Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25798669
Citation
Franssen LE, van de Donk NW, Emmelot ME, Roeven MW, Schaap N, Dolstra H, Hobo W, Lokhorst HM, Mutis T. The impact of circulating suppressor cells in multiple myeloma patients on clinical outcome of DLIs. Bone Marrow Transplant. 2015 Jun;50(6):822-8. doi: 10.1038/bmt.2015.48. Epub 2015 Mar 23.
Results Reference
result
PubMed Identifier
25760767
Citation
Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813.
Results Reference
result
Learn more about this trial
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "
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