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

Vejle Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02419118

181114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Accepted for a clinical trial with Daratumumab for myeloma

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Dara len dex

Experimental group

Description:

Daratumumab in combination with lenalidomide and dexamethasone

Treatment:

Drug: Dexamethasone

Drug: Daratumumab

Drug: Lenalidomide

Len dex

Active Comparator group

Description:

Lenalidomide in combination with dexamethasone

Treatment:

Drug: Dexamethasone

Drug: Lenalidomide