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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02419118
Other study ID # 181114
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 12, 2015
Last updated November 6, 2017
Start date January 2015
Est. completion date October 1, 2015

Study information

Verified date November 2017
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date October 1, 2015
Est. primary completion date October 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Daratumumab
Treatment of myeloma patients with Daratumumab
Lenalidomide
Treatment of myeloma patients
Dexamethasone
Treatment of myeloma patients

Locations

Country Name City State
Denmark Department of Hematology Vejle Hospital Vejle

Sponsors (1)

Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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: — View Citation

Overdijk MB, Verploegen S, Bögels 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 lymp — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Response by IMWG criteria Assessed by M-component in blood and urine samples 4 weeks
Secondary T cell subset numbers Measured in bood and bone marrow aspirates 4 weeks
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