A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

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• Multiple Myeloma 3,632

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 228 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  Part 1: Dose Escalation

  Participants will receive tec+tal in 28-day cycles following initial step-up doses. Upon sponsor notification, participants will enter the long-term extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.

  Drug: Talquetamab · Drug: Teclistamab

• Experimental
  Part 2: Dose Expansion

  Participants will receive treatment doses (combination of tal+tec regimen) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.

  Drug: Talquetamab · Drug: Teclistamab

• Experimental
  Part 3: Phase 2

  Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.

  Drug: Talquetamab · Drug: Teclistamab

Interventions

• DrugTalquetamab

  Talquetamab will be administered by subcutaneous (SC) injection.

  Also known as: JNJ-64407564

• DrugTeclistamab

  Teclistamab will be administered by SC injection.

  Also known as: JNJ-64007957

Primary outcomes

1. Part 1: Number of Participants with Dose Limiting Toxicity (DLT)

   The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.

   Time frame: Approximately 5 years 10 months

2. Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

   Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

   Time frame: Approximately 5 years 10 months

3. Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

   An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.

   Time frame: Approximately 5 years 10 months

4. Part 2: Number of Participants with Adverse Events and SAEs by Severity

   Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

   Time frame: Approximately 5 years 10 months

5. Part 3: Overall Response Rate (ORR)

   ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).

   Time frame: Approximately 5 years 10 months

Secondary outcomes

1. Parts 1, 2 and 3: Serum Concentration of Talquetamab

   Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.

   Time frame: Approximately 5 years 10 months

2. Parts 1, 2 and 3: Serum Concentration of Teclistamab

   Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.

   Time frame: Approximately 5 years 10 months

3. Part 1 and Part 2: Serum Concentration of Daratumumab

   Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.

   Time frame: Approximately 5 years 10 months

4. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab

   Number of participants with anti-drug antibodies to talquetamab will be assessed.

   Time frame: Approximately 5 years 10 months

5. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab

   Number of participants with anti-drug antibodies to teclistamab will be assessed.

   Time frame: Approximately 5 years 10 months

6. Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab

   Number of participants with anti-drug antibodies to daratumumab will be assessed.

   Time frame: Approximately 5 years 10 months

7. Part 1 and Part 2: Overall Response Rate (ORR)

   ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.

   Time frame: Approximately 5 years 10 months

8. Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate

   VGPR or better response rate (sCR+CR+VGPR) is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria.

   Time frame: Approximately 5 years 10 months

9. Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate

   CR or better response rate (sCR+CR) is defined as the percentage of participants who achieve a CR or better response according to the IMWG criteria.

   Time frame: Approximately 5 years 10 months

10. Part 1, 2 and 3: Stringent Complete Response (sCR) Rate

    sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.

    Time frame: Approximately 5 years 10 months

11. Parts 1, 2 and 3: Duration of Response (DOR)

    DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.

    Time frame: Approximately 5 years 10 months

12. Parts 1, 2 and 3: Time to Response

    Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

    Time frame: Approximately 5 years 10 months

13. Part 3: Progression free Survival (PFS)

    PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

    Time frame: Approximately 5 years 10 months

14. Part 3: Overall Survival (OS)

    OS is measured from the date of first dose to the date of the participant's death.

    Time frame: Approximately 5 years 10 months

15. Part 3: Number of Participants with Adverse Events

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Time frame: Approximately 5 years 10 months

16. Part 3: Number of Participants with Adverse Events by Severity

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

    Time frame: Approximately 5 years 10 months

Publications

• Kumar S, Mateos MV, Ye JC, Atrash S, Magen H, Quach H, Chu MP, Trudel S, Richter J, Rodriguez-Otero P, Chuah H, Gatt M, Medvedova E, Raza S, Yoon DH, Ishida T, Matous JV, Rosinol L, Onodera K, Scott E, Heuck C, Zhang J, Henninger T, O'Rourke L, Thakkar P, Festa M, Huang L, Zhou J, Takamoto M, Pei L, Lu J, Au N, Krevvata M, Usmani SZ, Cohen YC; RedirecTT-1 Investigators Study Group. Dual Targeting of Extramedullary Myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026 Jan 1;394(1):51-61. doi: 10.1056/NEJMoa2514752. Epub 2025 Dec 7. PubMed 41358582 ↗
• Cohen YC, Magen H, Gatt M, Sebag M, Kim K, Min CK, Ocio EM, Yoon SS, Chu MP, Rodriguez-Otero P, Avivi I, Quijano Carde NA, Kumar A, Krevvata M, Peterson MR, Di Scala L, Scott E, Hilder B, Vanak J, Banerjee A, Oriol A, Morillo D, Mateos MV; RedirecTT-1 Investigators and Study Group. Talquetamab plus Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025 Jan 9;392(2):138-149. doi: 10.1056/NEJMoa2406536. PubMed 39778168 ↗
• St Martin Y, Franz JK, Agha ME, Lazarus HM. Failure of CAR-T cell therapy in relapsed and refractory large cell lymphoma and multiple myeloma: An urgent unmet need. Blood Rev. 2023 Jul;60:101095. doi: 10.1016/j.blre.2023.101095. Epub 2023 Apr 29. PubMed 37173224 ↗

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.