Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 64007957MMY1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-004124-38 | EudraCT Number | ||
| 2023-503439-16-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | 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. |
|
| Part 2: Dose Expansion | Experimental | 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. |
|
| Part 3: Phase 2 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talquetamab | Drug | Talquetamab will be administered by subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 5 years 10 months |
| Parts 1, 2 and 3: Serum Concentration of Teclistamab |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Comprehensive Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41358582 | Derived | 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. | |
| 39778168 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Teclistamab | Drug | Teclistamab will be administered by SC injection. |
|
|
| 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). | Approximately 5 years 10 months |
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method. |
| Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| Part 3: Overall Survival (OS) | OS is measured from the date of first dose to the date of the participant's death. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| 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. | Approximately 5 years 10 months |
| University of Arkansas for Medical Sciences |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University St. Louis School Medicine Siteman Cancer Center | St Louis | Missouri | 63108 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health And Science University | Portland | Oregon | 97239 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| St Vincents Hospital Melbourne | Fitzroy | 3065 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| Alberta Health Services | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | M5G 1X6 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Kanazawa University Hospital | Kanazawa | 920-8641 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Inst. Cat. Doncologia-H Duran I Reynals | L'Hospitalet de Llobregat | 08908 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| UNIV. HOSP. October 12 | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Derived |
| 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. |
| 37173224 | Derived | 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. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2026 | Apr 6, 2026 | 61 | ||
| May 18, 2026 | Jun 12, 2026 | 62 | ||
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000730985 | talquetamab |
Not provided
Not provided
Not provided