18 and older, any sex, with Waldenström Macroglobulinemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· 2 years
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
Group
Value
95% CI
Daratumumab
3
Progression Free SurvivalSecondary· 4 years
Amount of time following daratumumab administration until \>25% increase in serum IgM
Group
Value
95% CI
Daratumumab
2
1 – 28
Number of Participants With Complete ResponseSecondary· 2 years
A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Group
Value
95% CI
Daratumumab
0
Number of Participants With Partial ResponseSecondary· 2 years
Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.
Group
Value
95% CI
Daratumumab
2
Number of Participants With Very Good Partial ResponseSecondary· 2 years
Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.
Group
Value
95% CI
Daratumumab
0
Number of Participants With Minor ResponseSecondary· 2 years
Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.
Group
Value
95% CI
Daratumumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other recruiting trials for Waldenström Macroglobulinemia
Currently open trials in the same condition.
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· Phase 2
· recruiting
NCT05294731 — Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Deg
· Phase 1, PHASE2
· recruiting
NCT01815749 — Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent
· Phase 1
· active not recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
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· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 23 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03187262.