Monoclonal antibodies for treatment of bone marrow cancer. multiple myeloma.

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 19.1Level: LLTClassification code 10028567Term: Myeloma, malignantSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005189-31-DK
• Lead Sponsor: Dept Hematology SLB Vejle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-16
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients that have been enrolled into a clinical trial MMY3003 for treatment of multiple myeloma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients not elegible for MMY3003

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To indentify factors that determine the activity of Daratumumab when used for treatment of multiple myeloma;Secondary Objective: To indentify factors that determine the activity of Daratumumab when used for treatment of multiple myeloma;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: As defined in MMY3003

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: As defined in MMY3003