Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC)	Up to approximately 2 years and 7 months	Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
Secondary	Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC	Up to approximately 2 years and 7 months	MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as ≥50% reduction of serum IgM from baseline.
Secondary	Duration of Response (DOR) as Assessed by IRC	Up to approximately 2 years and 7 months	DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline.
Secondary	DOR as Assessed by IRC: Event -Free Rate	12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)	Estimated percentage of participants who were event-free based on Kaplan-Meier method.
Secondary	Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator	Up to approximately 5 years and 5 months	Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
Secondary	DOR as Assessed by the Investigator	Up to approximately 5 years and 5 months	DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first
Secondary	DOR as Assessed by the Investigator: Event-Free Rate	24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)	Estimated percentage of participants who were event-free based on Kaplan-Meier method.
Secondary	Progression Free Survival (PFS) as Assessed by the IRC	Up to approximately 2 years and 7 months	PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia \[IWWM criteria\]) or death, whichever occurs first
Secondary	PFS as Assessed by IRC: Event-Free Rate	12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)	Estimated percentage of participants who were event-free based on Kaplan-Meier method
Secondary	PFS as Assessed by the Investigator	Up to approximately 5 years and 5 months	PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first.
Secondary	PFS as Assessed by the Investigator: Event-Free Rate	24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)	Percentage of participants who were event-free based on Kaplan-Meier method.
Secondary	Percentage of Participants With Resolution of All Treatment-precipitating Symptoms	Up to approximately 5 years and 5 months
Secondary	Percentage of Participants With an Anti-Lymphoma Effect	Up to approximately 5 years and 5 months	Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to approximately 5 years and 5 months

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT03053440/registered

API reference For AI assistants