~21 spots leftby Jun 2025

Talquetamab + Teclistamab for Multiple Myeloma (RedirecTT-1 Trial)

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Janssen Research & Development, LLC
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a combination of two drugs, talquetamab and teclistamab, in patients whose multiple myeloma has come back or did not respond to previous treatments. The drugs aim to destroy cancer cells by targeting specific proteins on their surface.

Eligibility Criteria

This trial is for people with multiple myeloma that's come back or hasn't responded to treatment. They should be able to perform daily activities without significant issues (ECOG grade 0-1). Participants must have been diagnosed according to specific criteria and can't join if they've had certain other conditions, recent experimental therapies, or a stem cell transplant within the last six months.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
My multiple myeloma diagnosis follows international guidelines.
My condition did not improve or worsened after the last treatment.

Exclusion Criteria

I had a stem cell transplant from a donor within the last 6 months.
I have a specific blood cancer or related condition.
My multiple myeloma has spread to my brain or spinal cord.

Treatment Details

The study is testing combinations of Talquetamab and Teclistamab in those with relapsed or refractory multiple myeloma. It aims to find the best dose and schedule, assess safety at this dose, and see how well these drugs work against cancer, especially when it has spread outside the bone marrow.
3Treatment groups
Experimental Treatment
Group I: Part 3: Phase 2Experimental Treatment2 Interventions
Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.
Group II: Part 2: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1.
Group III: Part 1: Dose EscalationExperimental Treatment3 Interventions
Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.
Daratumumab is already approved in European Union, United States for the following indications:
๐Ÿ‡ช๐Ÿ‡บ Approved in European Union as Darzalex for:
  • Relapsed and refractory multiple myeloma
  • Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
๐Ÿ‡บ๐Ÿ‡ธ Approved in United States as Darzalex for:
  • Multiple myeloma in patients who have received at least three prior therapies
  • Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
  • Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Find a clinic near you

Research locations nearbySelect from list below to view details:
Oregon Health And Science UniversityPortland, OR
Emory UniversityAtlanta, GA
Washington University St. Louis School Medicine Siteman Cancer CenterSaint Louis, MO
Arthur J. E. Child Comprehensive Cancer CentreCalgary, Canada
More Trial Locations
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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

References