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New treatment option for Relapsed Refractory Multiple Myeloma (RRMM)
Official title Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07032714
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed refractory multiple myeloma (rrmm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical...
- 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
You likely can't join if
- Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from...
- 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
See the full eligibility 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of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the...
- 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...
- 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...
- 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...
- Male people 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.