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

Multiple Myeloma Clinical Trial

— DARA  

Official title:

"Monoclonal Antibodies for Treatment of Multiple Myeloma. Present Status and Aspects of Effector Mechanisms With Emphasis on the CD38 Antibody Daratumumab "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419118
• Other study ID #: 181114
• 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
• 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:

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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