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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

RedirecTT-1 Trial Summary

This trial is designed to find the best doses and schedules of three drugs to treat COVID-19, and to learn more about the safety of these combinations.

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.Check my eligibility
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.See study design
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.

RedirecTT-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

RedirecTT-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

RedirecTT-1 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
~1860

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,165 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,253 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,762 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,220 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04586426 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Part 3: Phase 2, Part 2: Dose Expansion, Part 1: Dose Escalation
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04586426 — Phase 1 & 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586426 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the expected outcomes of this investigation?

"This clinical trial is anticipated to last a period of 18 months and will be used to evaluate the safety, tolerability and efficacy of an investigational medication. Primary aims include monitoring adverse events and serious adverse reactions while secondary objectives focus on complete response or better rate, overall response rate, and duration of response as defined by International Myeloma Working Group criteria."

Answered by AI

Does this trial still accept new participants?

"By consulting clinicaltrials.gov it is clear that this medical trial, which was first proposed on December 15th 2020, is still actively looking for patients to include in their study. The last time the information related to this research was modified was November 3rd 2022."

Answered by AI

Are there any other researches exploring the effects of Talquetamab?

"Currently, the world has 146 live studies researching Talquetamab with a quarter of them in their third phase. The majority are based out of Jacksonville, but there is an expansive network of 5792 trial sites that have been activated for this drug's research."

Answered by AI

To what extent is participant involvement in this investigation?

"Confirmed, clinicaltrials.gov shows that this medical experiment is actively recruiting individuals since its initial posting on December 15th 2020 and the last update was recorded on November 3rd 2022. 102 patients will be recruited from two different clinics."

Answered by AI

What diseases is Talquetamab typically employed as a treatment for?

"Talquetamab, a type of biological response modifier, is effective in the treatment of refractory and relapsed multiple myeloma."

Answered by AI

Has Talquetamab been certified by the FDA?

"The early stage clinical data on Talquetamab's safety and efficacy is limited, resulting in it being rated as a 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
2020. "A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04586426.
~54 spots leftby Jun 2025
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