Phase 2
N=13
A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Waldenström Macroglobulinemia
Bottom Line
View on ClinicalTrials.gov: NCT03187262 ↗Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Apr 2021
Primary outcome: Primary: Overall Response Rate — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Daratumumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
3 | — |
| SECONDARY Progression Free Survival |
2 | — |
| SECONDARY Number of Participants With Complete Response |
— | — |
| SECONDARY Number of Participants With Partial Response |
2 | — |
| SECONDARY Number of Participants With Very Good Partial Response |
— | — |
| SECONDARY Number of Participants With Minor Response |
1 | — |
Summary
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
Eligibility Criteria
Inclusion Criteria
- Clinicopathological diagnosis of Waldenström Macroglobulinemia (Owen et al. 2003), and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia (Kyle et al. 2003)
- At least one previous treatment for WM with either documented disease progression or no response (stable disease) to the most recent treatment regimen
- Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of >2 times the upper limit of normal of each institution is required
- Participants with symptomatic hyperviscosity or serum IgM >5,000 mg/dL to undergo plasmapheresis prior to treatment initiation
- Age ≥18 years
- ECOG performance status ≤2 (see Appendix A)
- Participants must have preserved organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 50,000/mcL
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 1.5 mg/dL or 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.
- History of non-compliance to medical regimens.
Data sourced from ClinicalTrials.gov (NCT03187262). 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.