Phase 2
Completed N=104
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
Source: ClinicalTrials.gov NCT00574288 ↗Enrolled (actual)
104
Serious AEs
38.5%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Adverse Events — 19; 3; 3; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
19; 3; 3; 3; 3; 30 | — |
| SECONDARY Overall Response Rate |
33.3; 0; 33.3; 66.7; 10.0; 35.7 | — |
| SECONDARY Part 1: Time to Response |
NA; NA; 8.4; 1.9; NA; NA | — |
| SECONDARY Part 2: Time to Progression (TTP) |
2.4; 5.6 | — |
| SECONDARY Part 2: Duration of Response as Assessed Using the Method of Kaplan-Meier |
6.9; NA | — |
| SECONDARY Part 2: Progression-Free Survival |
2.4; 5.6 | — |
| SECONDARY Part 2: Time to Response |
1.36; 1.33; 1.36; 2.46; 0.49 | — |
| SECONDARY Part 2: Overall Survival |
18.2; 34.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00574288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.