Waldenstrom's MacroglobulinemiaPhase 2NCT07791498
Teclistamab In Waldenstrom's Macroglobulinemia
A Phase 2 study testing Teclistamab in people with Waldenstrom's Macroglobulinemia, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this clinical trial is to assess the efficacy of teclistamab in participants with relapsed or refractory Waldenstrom's macroglobulinemia who have received prior therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- Teclistamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2027to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicopathological diagnosis of WM per IWWM2 criteria.
- Meeting criteria for treatment per IWWM2 criteria.
- Relapsed or refractory WM with at least 1 prior line of treatment, including an anti-CD20 monoclonal antibody containing regimen or a BTK inhibitor.
- Patients should have received a prior BTK inhibitor (except for contraindications such as bulky disease, amyloidosis, significant medication interactions, or a history of severe bleeding).
- Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
- Adults aged ≥18
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- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
- A female participant must be:
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception
- A male participant must wear a condom (with or without spermicidal foam/gel/film/ cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment.
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥500/mcL; the patient may enroll below this threshold if neutropenia is believed to be caused by WM bone marrow involvement. Growth factors are not permitted <14 days prior to C1D1.
- Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted <14 days prior to C1D1.
- Hemoglobin ≥ 8 g/dL. RBC transfusions are not permitted <14 days prior to C1D1.
- Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula
- Ability to adhere to the study visit schedule and other protocol requirements.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Received any prior BCMA-directed therapy.
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form.
- Participants who are receiving any other investigational agents for this condition.
- Participants with known CNS lymphoma.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study.
- History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection.
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- Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T cell count of >/=200 cells/microliter).
- Participants with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable, and if the participant is willing to take appropriate anti-viral prophylaxis as indicated and HBV DNA monitoring on study.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Note: Participants with serologic evidence of prior vaccination to HBV (i.e., HBs Ag-, and anti- HBs+ and anti-HBC-) and positive anti-HBc from IVIG may participate.
- Significant cardiovascular disease defined as:
- Unstable angina within the past 6 months, or
- History of myocardial infarction within the past 6 months
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
- Uncontrolled or symptomatic arrhythmias
- Concurrent systemic immunosuppressant therapy. Systemic steroids at doses <20mg prednisone per day are permitted.
- Concurrent systemic anti-Waldenstrom therapy.
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.
- Major surgery within 4 weeks of first dose of study drug.
- Participants with a known hypersensitivity to any of the excipients of Teclistamab.
- Participants with a history of non-compliance to medical regimens, which will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- History of a non-lymphoma malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that is in a complete remission.
- Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Andrew Branangan, MD, PhD, 617-724-4000, abranagan@mgh.harvard.edu
Andrew Branagan, MD, PhD
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Tarek Mouhieddine, MD, 855-281-2811, TAREK_MOUHIEDDINE@DFCI.HARVARD.EDU
Tarek Mouhieddine, MD
About this study
Official title: A Phase 2 Study of Teclistamab in Relapsed or Refractory Waldenstrom's Macroglobulinemia
The goal of this clinical trial is to assess the efficacy of teclistamab in participants with relapsed or refractory Waldenstrom's macroglobulinemia who have received prior therapy. This study also aims to assess the safety and tolerability of teclistamab, how quickly and to what extent response is seen in participants, how strong any clinical benefit of teclistamab might be, and determine the response to teclistamab based on the combination of MY88 and CXCR4 mutations. The main questions it aims to answer are:
- Will teclistamab be effective in treating Waldenstrom's macroglobulinemia?
- By targeting BCMA with teclistamab, will direct Waldenstrom's macroglobulinemia tumor death occur? Participants will receive teclistamab for up to 9 cycles (cycle 1 is 14 days, cycles 2-5 are 28 days, and cycles 6-9 are 56 days) or until their disease progresses, another illness or change in their condition prevents them from further receiving the treatment, they experience unacceptable side effects, they demonstrate an inability or unwillingness to receive the medication regimen, or they decide to withdraw from the study. Participants will be followed for up to 3 years from the last treatment.
Read the detailed description
This is an open label phase II study that will enroll 24 patients with relapsed or refractory Waldenstrom's macroglobulinemia after one or more lines of systemic therapy for WM, including an anti-CD20 monoclonal antibody-containing regimen or a BTK inhibitor. This research study is evaluating a less frequent and shorter dosing schedule of teclistamab compared to the approved dosing schedule for individuals with multiple myeloma, which includes more frequent dosing in early treatment cycles and continuing to receive teclistamab until disease progression or unacceptable side effects occur. Johnson \& Johnson is supporting this research study by providing the study drug, teclistamab, and funding for the clinical trial activities. The U.S. Food and Drug Administration (FDA) has not approved teclistamab for relapsed or refractory Waldenstrom's macroglobulinemia, but it has been approved to treat other types of multiple myeloma that has come back or been difficult to treat. Teclistamab is a type of antibody-based medication that attaches to both cancer cells and the body's T cells (a type of immune cell). By connecting the two, teclistamab bring T cells close enough to the cancer cells so they can activate and kill the cancer cells directly, without needing usual immune-system signals.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- Teclistamab
- Keywords
- relapsed, refractory, waldenstrom's macroglobulinemia, teclistamab, WM
- Medical subject headings
- Waldenstrom Macroglobulinemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Safety and tolerability will be assessed by the grade and category of any adverse events. Adverse events will be classified and graded using CTCAE v5.0 and summarized by category and highest grade per participant.
Measured: 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
Immunoglobulin M (IgM) Major Response Rate (MRR) includes PR, VGPR, and CR responses. Partial response (PR) is defined as achieving a >50% reduction in serum IgM levels, with reduction in extramedullary disease. Very Good Partial Response (VGPR) is defined as a >90% reduction in serum IgM levels, or normalization of serum IgM levels with persistent IgM monoclonal spike in SPEP or immunofixation, and complete resolution of extramedullary disease. Complete Response (CR) is defined as having resolution of Waldenstrom's Macroglobulinemia related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Responses rates will be presented with exact 95% confidence intervals.
Measured: 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
Median time to response is defined as the average time from first treatment dose to first documentation of any response. Time to response event will be summarized using the Kaplan-Meier method.
Measured: 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
Median time to major response is defined as the average time from the first treatment dose to the first documentation of a major response. Major response includes partial response, very good partial response, and complete response. Time to response event will be summarized using the Kaplan-Meier method.
Measured: 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
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment of time of objective disease progression (including initiation of new therapy or death). Median, 2-year, and 4-year landmark PFS analysis will be determined. Time to event will be summarized using the Kaplan-Meier method.
Measured: 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.
Overall Survival
Overall Survival (OS) is defined as the duration of time from start of treatment to time of death or last follow-up. Median, 2-year, and 4-year landmark OS analysis will be determined. Time to event will be summarized using the Kaplan-Meier method.
Measured: Day 1 of cycle 1 (cycle 1 is 14 days) to death or last follow-up, whichever occurs first, up to 3 years from last treatment date.
Overall Response Rate by Mutational Status
Overall response rate (ORR) includes patients who achieved minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR). Mutational status is based on the combination of MY88 and CXCR4 mutations. Response rate will be presented with exact 95% confidence intervals.
Measured: Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of MR, PR, VGPR, and/or CR up to 3 years from last treatment date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start19 Feb 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Andrew R. Branagan, M.D., Ph.D., Massachusetts General Hospital
- Investigators
- Andrew Branagan, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791498
- Sponsor's protocol ID
- 26-302
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Request may be directed to: Andrew Branagan, MD, PhD at abrangan@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Teclistamab in Relapsed or Refractory Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT07791498
- Acronym / sponsor ID
- 26-302
- Conditions
- Waldenstrom's Macroglobulinemia
- Keywords
- relapsed, refractory, waldenstrom's macroglobulinemia, teclistamab, WM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 19 Feb 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the efficacy of teclistamab in participants with relapsed or refractory Waldenstrom's macroglobulinemia who have received prior therapy. This study also aims to assess the safety and tolerability of teclistamab, how quickly and to what extent response is seen in participants, how strong any clinical benefit of teclistamab might be, and determine the response to teclistamab based on the combination of MY88 and CXCR4 mutations. The main questions it aims to answer are:
- Will teclistamab be effective in treating Waldenstrom's macroglobulinemia?
- By targeting BCMA with teclistamab, will direct Waldenstrom's macroglobulinemia tumor death occur? Participants will receive teclistamab for up to 9 cycles (cycle 1 is 14 days, cycles 2-5 are 28 days, and cycles 6-9 are 56 days) or until their disease progresses, another illness or change in their condition prevents them from further receiving the treatment, they experience unacceptable side effects, they demonstrate an inability or unwillingness to receive the medication regimen, or they decide to withdraw from the study. Participants will be followed for up to 3 years from the last treatment.
Detailed description
This is an open label phase II study that will enroll 24 patients with relapsed or refractory Waldenstrom's macroglobulinemia after one or more lines of systemic therapy for WM, including an anti-CD20 monoclonal antibody-containing regimen or a BTK inhibitor. This research study is evaluating a less frequent and shorter dosing schedule of teclistamab compared to the approved dosing schedule for individuals with multiple myeloma, which includes more frequent dosing in early treatment cycles and continuing to receive teclistamab until disease progression or unacceptable side effects occur. Johnson \& Johnson is supporting this research study by providing the study drug, teclistamab, and funding for the clinical trial activities. The U.S. Food and Drug Administration (FDA) has not approved teclistamab for relapsed or refractory Waldenstrom's macroglobulinemia, but it has been approved to treat other types of multiple myeloma that has come back or been difficult to treat. Teclistamab is a type of antibody-based medication that attaches to both cancer cells and the body's T cells (a type of immune cell). By connecting the two, teclistamab bring T cells close enough to the cancer cells so they can activate and kill the cancer cells directly, without needing usual immune-system signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teclistamab | Experimental | Drug: TeclistamabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Clinicopathological diagnosis of WM per IWWM2 criteria.
- Meeting criteria for treatment per IWWM2 criteria.
- Relapsed or refractory WM with at least 1 prior line of treatment, including an anti-CD20 monoclonal antibody containing regimen or a BTK inhibitor.
- Patients should have received a prior BTK inhibitor (except for contraindications such as bulky disease, amyloidosis, significant medication interactions, or a history of severe bleeding).
- Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
Key exclusion criteria (25 listed)
- Received any prior BCMA-directed therapy.
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form.
- Participants who are receiving any other investigational agents for this condition.
- Participants with known CNS lymphoma.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabSubcutaneous 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. | Drug | Teclistamab |
Primary outcome
Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia
Time frame: 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.
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.
7 secondary outcomes
Safety and Tolerability of Teclistamab
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Overall Survival
Time frame: Day 1 of cycle 1 (cycle 1 is 14 days) to death or last follow-up, whichever occurs first, up to 3 years from last treatment date.
Overall Response Rate by Mutational Status
Time frame: Day 1 of cycle 1 (cycle 1 is 14 days) to first documentation of MR, PR, VGPR, and/or CR up to 3 years from last treatment date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Request may be directed to: Andrew Branagan, MD, PhD at abrangan@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Branagan, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab in people with Waldenstrom's Macroglobulinemia, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Branangan, MD, PhD (617-724-4000, abranagan@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Immunoglobulin M Response in Relapsed or Refractory Participants with Waldenstrom's Macroglobulinemia (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.