Trials Sponsors Conditions Drugs Pricing

Conditions

Waldenstrom's Macroglobulinemia

Keywords

relapsedrefractorywaldenstrom's macroglobulinemiateclistamabWM

Outcome Measures

Primary Outcomes (1)

Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia
Overall immunoglobulin M (IgM) efficacy will be evaluated by assessing the IgM response rate and the objective response rate (ORR, PR or better; at least 25% improvement in IgM from baseline). Overall response rate (ORR) includes patients who achieved minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR). Response rates will be presented with exact 95% confidence intervals. With 24 patients, there is 99% power to reject a null rate of IgM response of 0.30 assuming an alternative IgM response rate of 0.70 based on the exact binomial exact test with a one-sided significance level of 0.03. The alternative IgM response rate will be rejected if at least 12 of 24 patients have a response.
Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of ORR, PR or better up to 3 years from the last treatment date.

Secondary Outcomes (7)

Safety and Tolerability of Teclistamab
Day 1 of cycle 1 (cycle 1 is 14 days) to end of follow-up phase, up to 3 years from the last treatment date.
Immunoglobulin M Major Response Rate
Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of PR, VDPR, and/or CR up to 3 years from the last treatment date.
Median Time to Response
Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of any response up to 3 years after last treatment date.
Median Time to Major Response
Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of major response up to 3 years from last treatment date.
Progression-Free Survival
Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of disease progression, initiation of new therapy, or death, whichever occurs first, up to 3 years from the last treatment date.
+2 more secondary outcomes

Study Arms (1)

Teclistamab

EXPERIMENTAL

Participants with relapsed or refractory Waldenstrom's macroglobulinemia will receive teclistamab. Teclistamab will be administered at the pre-determined dose on days 1, 4, and 7 of the first 14-day cycle via subcutaneous injection into their abdomen. Then, participants will be given teclistamab once every week for up to four 28-day cycles, and then for up to four 56-day cycles, with a maximum of 9 cycles.

Drug: Teclistamab

Interventions

TeclistamabDrug

Subcutaneous injection into the abdomen received on days 1, 4, and 7 of the first 14-day cycle, then every week for up to four 28-day cycles, and then for up to four 56-day cycles, with a maximum of 9 cycles.

Teclistamab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinicopathological diagnosis of WM per IWWM2 criteria.
Meeting criteria for treatment per IWWM2 criteria.

Sponsors & Collaborators

Johnson & Johnson
Industrycollaborator
Massachusetts General Hospital
Otherlead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Andrew Branangan, MD, PhDCONTACT617-724-4000 abranagan@mgh.harvard.edu

Andrew Branagan, MD, PhDPRINCIPAL INVESTIGATOR

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Tarek Mouhieddine, MDCONTACT855-281-2811 TAREK_MOUHIEDDINE@DFCI.HARVARD.EDU

Tarek Mouhieddine, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Waldenstrom MacroglobulinemiaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic Diseases

Study Officials

Andrew Branagan, MD, PhD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Branangan, MD, PhD

CONTACT

617-724-4000 abranagan@mgh.harvard.edu

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 28, 2026

Study Start

February 19, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

September 1, 2027

Teclistamab In Waldenstrom's Macroglobulinemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Teclistamab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Teclistamab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations