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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-14
• Last Update Posted: 26 February 2018

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 from 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

Study & Design

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