Daratumumab (HuMax-CD38) safety study in multiple myeloma – Open label, dose-escalation followed by open label, single-arm study

Phase 1

• Conditions: Multiple myeloma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 19.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2007-003783-22-DK
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Documented diagnosis of multiple myeloma requiring systemic therapy
2. Age = 18 years.
3. ECOG performance status (0-2).
4. Life expectancy > 3 months.
5. Relapsed or refractory to two or more different prior therapies
6. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Plasma cell leukemia defined as a plasma cell count > 2000/mm3.
2. Known amyloidosis
3. Patients who previously have received an allogenic stem cell transplant and receive or have received immunosuppressive therapy within the last three months.

Study & Design

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