Phase 2
Completed N=124
An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
Source: ClinicalTrials.gov NCT01985126 ↗Enrolled (actual)
124
Serious AEs
31.5%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants With Overall Response — 11.1; 29.2 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are double refractory to a PI and an IMiD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response |
11.1; 29.2 | — |
| SECONDARY Duration of Response |
NA; 7.4 | — |
| SECONDARY Overall Survival |
19.45; 18.60 | — |
| SECONDARY Percentage of Participants With Clinical Benefit |
22.2; 34.0 | — |
| SECONDARY Time to Response |
0.99; 0.99 | — |
| SECONDARY Progression Free Survival |
4.86; 3.65 | — |
| SECONDARY Time to Disease Progression |
4.86; 3.71 | — |
Eligibility Criteria
Inclusion Criteria
- Documented multiple myeloma according to protocol-defined criteria
- Evidence of disease progression on the most recent prior treatment regimen 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01985126). 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.