Is NCT07032714 recruiting in Boston, MA?

Yes, NCT07032714 is currently recruiting participants at its Boston, MA location. This relapsed refractory multiple myeloma (rrmm) clinical trial is actively enrolling qualified participants.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Relapsed Refractory Multiple Myeloma (RRMM) Clinical Trial in Boston, MA

Q: How do I join the relapsed refractory multiple myeloma (rrmm) clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Relapsed Refractory Multiple Myeloma (RRMM) Study in Boston

This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix).

Age ≥ 18 years

Measurable disease of multiple myeloma as defined by at least one of the following:

Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval

≥ 200 mg of monoclonal protein in the urine on 24-hour urine protein electrophoresis

Serum free light chain (FLC) ≥ 100 mg/L (10 mg/dL) and abnormal serum free light chain ratio

Previously treated relapsed and refractory multiple myeloma:

Patients must have received at least three prior lines of therapy;

Prior therapy including an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody (either in separate regimens or within the same regimen); and

Disease progression on, or within 60 days of completion of last therapy.

ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening.

Platelet count ≥ 50,000/µL. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening.

Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.

Calculated creatinine clearance of ≥ 30 mL/min by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula

Serum bilirubin values \< 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \<3 mg/dL and normal direct bilirubin); and

Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.

Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent.

Females of childbearing potential (FCBP) must:

Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. The subject must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.

Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by the Pregnancy Prevention Plan.

Male subjects must follow the mezigdomide Pregnancy Prevention Plan (see Appendix).

Agree to follow the lifestyle considerations in Section 3.4 regarding blood donation, hospitalization and being in proximity to the hospital, and driving or operating heavy machinery.

Exclusion Criteria

Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.

Participants who are receiving any investigational agents.

Prior therapy with mezigdomide or iberdomide.

Prior therapy with anti-GPRC5D therapy (e.g. talquetamab).

Prior therapy with bispecific antibody therapy within three months

Prior therapy with gene-modified adoptive cell therapy (e.g. CAR T-cells, NK cells) within three months

Plasmapheresis within seven days prior to start of study treatment.

Primary refractory disease.

Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg/day or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07032714) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Relapsed Refractory Multiple Myeloma (RRMM) Treatment Options in Boston, MA

If you're searching for relapsed refractory multiple myeloma (rrmm) treatment options in Boston, MA, this clinical trial (NCT07032714) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsed refractory multiple myeloma (rrmm) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all relapsed refractory multiple myeloma (rrmm) clinical trials near you to find additional studies recruiting in your area.

Relapsed Refractory Multiple Myeloma (RRMM) Clinical Trial in Boston, MA

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