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Monoclonal Antibodies
Talquetamab + Teclistamab for Multiple Myeloma (RedirecTT-1 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Must not have
Allogeneic stem cell transplant within 6 months before the first dose of study treatment
Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, bone pain from disease activity changes due to treatment response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My multiple myeloma diagnosis follows international guidelines.
Select...
My condition did not improve or worsened after the last treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a stem cell transplant from a donor within the last 6 months.
Select...
I have a specific blood cancer or related condition.
Select...
My multiple myeloma has spread to my brain or spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Number of Participants with Dose Limiting Toxicity (DLT)
Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
+2 moreSecondary study objectives
Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab
Part 1 and Part 2: Overall Response Rate (ORR)
Part 1 and Part 2: Serum Concentration of Daratumumab
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2000
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Myeloma include immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and bispecific antibodies. Bispecific antibodies, such as Talquetamab and Teclistamab, are designed to engage T-cells by targeting specific antigens on myeloma cells (GPRC5D and BCMA, respectively) and CD3 on T-cells, thereby directing the immune system to attack the cancer cells.
This mechanism is crucial for Multiple Myeloma patients as it offers a targeted approach to eliminate malignant cells while potentially reducing damage to normal cells. Other treatments like proteasome inhibitors disrupt protein degradation in cancer cells, leading to apoptosis, and immunomodulatory drugs enhance the immune response against myeloma cells.
Monoclonal antibodies target specific proteins on myeloma cells to mark them for destruction by the immune system. These therapies collectively improve response rates and duration of remission in Multiple Myeloma patients.
How best to use new therapies in multiple myeloma.
How best to use new therapies in multiple myeloma.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,398,099 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,905 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
770 Previous Clinical Trials
3,973,839 Total Patients Enrolled
53 Trials studying Multiple Myeloma
14,826 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stem cell transplant from a donor within the last 6 months.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had targeted, epigenetic, or investigational treatments recently.My multiple myeloma diagnosis follows international guidelines.My condition did not improve or worsened after the last treatment.I have a specific blood cancer or related condition.My multiple myeloma has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Part 3: Phase 2
- Group 2: Part 2: Dose Expansion
- Group 3: Part 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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