Overview
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
Status:
Completed
Completed
Trial end date:
2017-04-03
2017-04-03
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
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