Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

• Status: Completed
• Trial end date: 2017-04-03
• Target enrollment: 0
• Participant gender: All

Summary

Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Daratumumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion criteria

• Diagnosis of multiple myeloma (MM) requiring systemic therapy

• Age greater than or equal to (>=) 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Life expectancy greater than (>) 3 months

• Relapsed from or refractory to two or more different prior therapies

• Signed Informed consent

Exclusion criteria

• Plasma cell leukemia defined as a plasma cell count > 2000/millimeter^3 (mm^3)

• Known amyloidosis

• Participants who previously have received an allogeneic stem cell transplant

• Sensory or motor neuropathy of >= grade 3

• Past or current malignancy

• Chronic or ongoing active infectious disease

• Clinically significant cardiac disease

• Significant concurrent, uncontrolled medical condition including, but not limited to, renal (except related to MM), hepatic, hematological except MM, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease

• A baseline QT interval as corrected by Fridericia's formula > 470 millisecond (msec) for female participants or > 450 msec for male participants or a complete left bundle branch block (defined as a QRS interval >= 120 msec in left bundle branch block form)

• Hypokalemia

• Clinical signs of meningeal involvement of MM

• Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than (<) 60 percentage (%) of expected

• History of significant cerebrovascular disease

• Known Human Immunodeficiency Virus seropositivity

• Positive serology for hepatitis B

• Screening laboratory values

• Concomitant corticosteroid

• Other chemotherapy that is or may be active against myeloma within 3 weeks prior to Visit 2 (Part 1) or the first dose of daratumumab (Part 2). However, corticosteroid for myeloma (less than a 4-day course) could be administered within 1 week before Visit 2 (Part 1) or the first dose of daratumumab (Part 2)

• Known hypersensitivity to components of the investigational product or severe allergic or anaphylactic reactions to humanized products

• Participants who have received treatment with any nonmarket drug substance within 4 weeks before the first dose of daratumumab

• Current participation in any other interventional clinical trial

• Participants known or suspected of not being able to comply with a trial protocol (example, due to alcoholism, drug dependency, or psychological disorder)

• Breastfeeding women or women with a positive pregnancy test at Screening

• Women of childbearing potential not willing to use adequate contraception, defined as hormonal birth control or intrauterine device, during the trial and for 1 year after the last dose of daratumumab. For participants in the United States, the use of a double-barrier method is also considered adequate