Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
Completed · Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT00574288
- Run by
- Janssen Research & Development, LLC
- People needed
- 104
- Starts
- 2008-03-26
- Expected to finish
- 2017-04-03
- Last updated by the study team
- 2018-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Boston, Massachusetts, United States
- Study site — Copenhagen Ø, Denmark
- Study site — Vejle, Denmark
- Study site — Amsterdam, Netherlands
- Study site — Utrecht, Netherlands
- Study site — Huddinge, Sweden
- Study site — Lund, Sweden
Full record on ClinicalTrials.gov
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