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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Lenalidomide; Drug: Daratumumab; Drug: Dexamethasone

• Registration Number: NCT02419118
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-17
• Primary Completion: 2015-10-01
• Study Completion: 2015-10-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Len dex	Lenalidomide	Lenalidomide in combination with dexamethasone
Dara len dex	Daratumumab	Daratumumab in combination with lenalidomide and dexamethasone
Dara len dex	Lenalidomide	Daratumumab in combination with lenalidomide and dexamethasone
Dara len dex	Dexamethasone	Daratumumab in combination with lenalidomide and dexamethasone
Len dex	Dexamethasone	Lenalidomide in combination with dexamethasone

Primary Outcome Measures

Name	Time	Method
Response by IMWG criteria	4 weeks	Assessed by M-component in blood and urine samples

Secondary Outcome Measures

Name	Time	Method
T cell subset numbers	4 weeks	Measured in bood and bone marrow aspirates

Trial Locations

Locations (1)

Department of Hematology Vejle Hospital; 🇩🇰 Vejle, Denmark