2022-502446-27-00RecruitingPhase 3
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Janssen - Cilag International80 sites in 9 countries423 target enrollmentStarted: February 13, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 423
- Locations
- 80
- Primary Endpoint
- Progression-Free Survival
Study Overview
Brief Summary
To compare the efficacy of either Tal-P or Tal-Tec with EPd or PVd
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- •Documented multiple myeloma as defined by the criteria below: a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria. b. Measurable disease at screening as assessed by central laboratory, defined by any of the following:
- •Serum M-protein level ≥0.5 g/dL (central laboratory); or
- •Urine M-protein level ≥200 mg/24 hours (central laboratory); or
- •Light chain multiple myeloma without measurable M protein in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio (central laboratory)
- •Relapsed or refractory disease as defined below: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment. b. Refractory disease is defined as <25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
- •Documented evidence of progressive disease or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen.
- •Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment.
Exclusion Criteria
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab IB, teclistamab IB, and appropriate prescribing information).
- •Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
- •Presence of the following cardiac conditions: a. New York Heart Association Class III or IV congestive heart failure b. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to randomization c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d. History of severe non-ischemic cardiomyopathy
- •Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- •Prior or concurrent exposure to any of the following, in the specified time frame prior to randomization: o T cell redirection therapy (for example, antibody therapy or BiTEs) within 3 months o Gene-modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells) within 3 months o Targeted therapy, epigenetic therapy, mAb therapy, cytotoxic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less o Investigational vaccine other than SARS CoV-2 vaccine approved or authorized for emergency use within 4 weeks o Live, attenuated vaccine within 4 weeks. Non-live and non-replicating vaccines approved or authorized for emergency use (e.g., COVID-19) by local health authorities are allowed. o PI therapy within 14 days o IMiD agent therapy within 14 days o Focal radiation within 7 days
Outcomes
Primary Outcomes
Progression-Free Survival
Progression-Free Survival
Secondary Outcomes
No secondary outcomes reported
Investigators
CITIS Point of Contact
Scientific
Janssen - Cilag International
Study Sites (80)
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