A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (RedirecTT-1)
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ClinicalTrials.gov Identifier: NCT04586426 |
Recruitment Status :
Recruiting
First Posted : October 14, 2020
Last Update Posted : August 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: Talquetamab Drug: Teclistamab Drug: Daratumumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 56 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Dose Escalation Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
Actual Study Start Date : | December 15, 2020 |
Estimated Primary Completion Date : | November 16, 2023 |
Estimated Study Completion Date : | May 28, 2024 |

Arm | Intervention/treatment |
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Experimental: Part 1: Dose Escalation
Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.
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Drug: Talquetamab
Talquetamab will be administered by subcutaneous (SC) injection.
Other Name: JNJ-64407564 Drug: Teclistamab Teclistamab will be administered by SC injection.
Other Name: JNJ-64007957 Drug: Daratumumab Daratumumab will be administered by SC injection. |
Experimental: Part 2: Dose Expansion
Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the RP2R(s) of the study treatment identified in Part 1.
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Drug: Talquetamab
Talquetamab will be administered by subcutaneous (SC) injection.
Other Name: JNJ-64407564 Drug: Teclistamab Teclistamab will be administered by SC injection.
Other Name: JNJ-64007957 Drug: Daratumumab Daratumumab will be administered by SC injection. |
- Part 1: Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Up to 1 year and 6 months ]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.
- Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 1 year and 6 months ]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.
- Part 2: Number of Participants with Adverse Events and SAEs by Severity [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1 and Part 2: Serum Concentration of Talquetamab [ Time Frame: Up to 1 year and 6 months ]Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.
- Part 1 and Part 2: Serum Concentration of Teclistamab [ Time Frame: Up to 1 year and 6 months ]Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.
- Part 1 and Part 2: Serum Concentration of Daratumumab [ Time Frame: Up to 1 year and 6 months ]Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.
- Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Talquetamab [ Time Frame: Up to 1 year and 6 months ]Number of participants with anti-drug antibodies to talquetamab will be assessed.
- Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Teclistamab [ Time Frame: Up to 1 year and 6 months ]Number of Participants with anti-drug antibodies to teclistamab will be assessed.
- Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 1 year and 6 months ]Number of Participants with anti-drug antibodies to daratumumab will be assessed.
- Part 1 and Part 2: Overall Response Rate (ORR) [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1 and Part 2: Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1 and Part 2: Complete Response (CR) or Better Response Rate [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1 and Part 2: Stringent Complete Response (sCR) Rate [ Time Frame: Up to 1 year and 6 months ]sCR rate is defined as the percentage of participants who achieve a sCR according to the IMWG criteria.
- Part 1 and Part 2: Duration of Response (DOR) [ Time Frame: Up to 1 year and 6 months ]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.
- Part 1 and Part 2: Time to Response [ Time Frame: Up to 1 year and 6 months ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria based on documented medical history
- Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy (except as noted in point 'a' and 'b'). (a) For cohorts without daratumumab, prior lines of therapy must include a proteasome inhibitor (PI) (example, bortezomib, carfilzomib, ixazomib), an immunomodulatory drug (IMiD) (example, thalidomide, lenalidomide, pomalidomide), and an anti-CD38 therapy (example, daratumumab, isatuximab) in any order. (b) For cohorts with daratumumab, prior lines of therapy must include a PI (example, bortezomib, carfilzomib, ixazomib) and an IMiD (example, thalidomide, lenalidomide, pomalidomide). Treatment with an anti-CD38 therapy (example, daratumumab) is allowed greater than equal to (>=) 90 days prior to study treatment if the participant did not discontinue prior treatment due to adverse events related to anti-CD38 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration
- Women of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 24 hours prior to the first step-up dose and the first dose of each treatment cycle
- Men must agree not to donate sperm for reproduction during the study and for a minimum 100 days after receiving the last dose of study treatment
Exclusion Criteria:
- Prior anticancer therapy as follows: a) targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; b) monoclonal antibody treatment for multiple myeloma within 21 days; c) cytotoxic therapy within 21 days; d) proteasome inhibitor (PI) therapy within 14 days; e) immunomodulatory drug (IMiD) therapy within 7 days; f) radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy; g) gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months
- A cumulative dose of corticosteroids equivalent to more than or equal to (>=) 140 milligram (mg) of prednisone within 14 days
- Live, attenuated vaccine within 4 weeks prior to first dose of study drug unless approved by sponsor
- Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV RNA testing
- Known allergies, hypersensitivity, or intolerance to daratumumab, talquetamab, teclistamab, or their excipients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586426
Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Canada, Alberta | |
Alberta Health Services | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Quebec | |
McGill University Health Centre | Recruiting |
Montreal, Quebec, Canada, H4A 3J1 | |
Israel | |
Hadassah Medical Center | Recruiting |
Jerusalem, Israel, 91120 | |
Sheba Medical Center | Recruiting |
Ramat Gan, Israel, 52621 | |
Tel-Aviv Sourasky Medical Center | Recruiting |
Tel-Aviv, Israel, 64239 | |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 06351 | |
The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Spain | |
Hosp. Univ. Germans Trias I Pujol | Recruiting |
Badalona, Spain, 08916 | |
Hosp. Univ. Fund. Jimenez Diaz | Recruiting |
Madrid, Spain, 28040 | |
Clinica Univ. de Navarra | Recruiting |
Pamplona, Spain, 31008 | |
Hosp. Clinico Univ. de Salamanca | Recruiting |
Salamanca, Spain, 37007 | |
Hosp. Univ. Marques de Valdecilla | Recruiting |
Santander, Spain, 39008 |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT04586426 |
Other Study ID Numbers: |
CR108901 2019-004124-38 ( EudraCT Number ) 64007957MMY1003 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | October 14, 2020 Key Record Dates |
Last Update Posted: | August 15, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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 |
URL: | https://www.janssen.com/clinical-trials/transparency |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Daratumumab Antineoplastic Agents |