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

November 6, 2017 updated by: Vejle Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Department of Hematology Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dara len dex
Daratumumab in combination with lenalidomide and dexamethasone
Drug: Daratumumab
Treatment of myeloma patients with Daratumumab
Other Names:
  • CD38 monoclonal antibody
  • HuMax CD38
Drug: Lenalidomide
Treatment of myeloma patients
Drug: Dexamethasone
Treatment of myeloma patients
Active Comparator: Len dex
Lenalidomide in combination with dexamethasone
Drug: Lenalidomide
Treatment of myeloma patients
Drug: Dexamethasone
Treatment of myeloma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response by IMWG criteria
Time Frame: 4 weeks
Assessed by M-component in blood and urine samples
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell subset numbers
Time Frame: 4 weeks
Measured in bood and bone marrow aspirates
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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