Daratumumab Study in Advanced Multiple Myeloma

Phase 1

Conditions: Multiple myeloma
MedDRA version: 16.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-000752-18-BE

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

Principal Inclusion Criteria in Lay Language (for a complete list of
inclusion criteria refer to the protocol):

- Documented multiple myeloma according to protocol-defined criteria
- Evidence of disease progression based on International Myeloma Working Group criteria
- Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
- Laboratory values and electrocardiogram within protocol-defined parameters at screening
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 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

Principal Exclusion Criteria in Lay Language (for a complete list of
exclusion criteria refer to the protocol):

- Received daratumumab or other anti-CD38 therapies previously
- Nonsecretory multiple myeloma
- Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
- Exhibiting clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
- Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
- Has plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis