A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2

Recruiting

• Conditions: Hematological Malignancies
• Interventions: Drug: Talquetamab

• Registration Number: NCT04634552
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Study Start: 2021-02-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
• Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory assessment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
• Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol

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Exclusion Criteria

• Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B and Cohort D: T cell redirection therapy within 3 months
• Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
• Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
• Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 3: Cohort A (Talquetamab)	Talquetamab	Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (\>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment.
Part 3: Cohort B (Talquetamab)	Talquetamab	Cohort B will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment.
Part 3: Cohort C (Talquetamab)	Talquetamab	Cohort C will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment.
Part 3: Cohort D (Talquetamab)	Talquetamab	Cohort D will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE phase upon communication by the sponsor.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 2 years and 10 months	ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 2 years and 10 months	PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
Duration of Response (DOR)	Up to 2 years and 10 months	DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
Complete Response (CR) or Better Rate	Up to 2 years and 10 months	CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
Stringent Complete Response (sCR) Rate	Up to 2 years and 10 months	sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
Time to Response (TTR)	Up to 2 years and 10 months	TTR 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.
Overall Survival (OS)	Up to 2 years and 10 months	OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Up to 2 years and 10 months	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Talquetamab Antibodies	Up to 2 years and 10 months	Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability	Up to 2 years and 10 months	An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants with Abnormalities in Clinical Laboratory Values	Up to 2 years and 10 months	Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)	Baseline up to 2 years and 10 months	The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Very Good Partial Response (VGPR) or Better Rate	Up to 2 years and 10 months	VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Minimal Residual Disease (MRD) Negative Rate	Up to 2 years and 10 months	MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.
Serum Concentration of Talquetamab	Up to 2 years and 10 months	Serum samples will be analyzed to determine concentrations of talquetamab.
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)	Baseline up to 2 years and 10 months	The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Number of Participants with AEs by Severity	Up to 2 years and 10 months	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). 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.
Overall Response Rate (ORR) in Participants with High-risk Molecular Features	Up to 2 years and 10 months	ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)	Baseline up to 2 years and 10 months	The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

Trial Locations

Locations (77)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

City of Hope; 🇺🇸 Duarte, California, United States

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States

Emory University - Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Washington University School Of Medicine; 🇺🇸 Saint Louis, Missouri, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

UCL - Saint Luc; 🇧🇪 Brussels, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

CHU de Liège - Domaine Universitaire du Sart Tilman; 🇧🇪 Liège, Belgium

Peking University Third Hospital; 🇨🇳 Beijing, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, China

The 1St Affiliated Hospital of Medical College Zhejiang University; 🇨🇳 Hangzhou, China

First Affiliated Hospital SooChow University; 🇨🇳 Su Zhou, China

Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science; 🇨🇳 Tianjin, China

The First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 XI An Shi, China

CHU de Montpellier Hopital Saint Eloi; 🇫🇷 Montpellier, France

C.H.U. Hotel Dieu - France; 🇫🇷 Nantes, France

CHU de Bordeaux - Hospital Haut-Leveque; 🇫🇷 Pessac cedex, France

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

CHU Henri Mondor; 🇫🇷 Creteil, France

Centre hospitalier Lyon-Sud; 🇫🇷 Pierre Benite cedex, France

Pôle IUC Oncopole CHU; 🇫🇷 Toulouse cedex 9, France

Charite Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Universitaetsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitaetsklinikum Muenster; 🇩🇪 Muenster, Germany

Universitatsklinikum Wurzburg; 🇩🇪 Wuerzburg, Germany

Rambam Medical Center; 🇮🇱 Haifa, Israel

Carmel Medical Center; 🇮🇱 Haifa, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Kameda Medical Center; 🇯🇵 Chiba, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

Ogaki Municipal Hospital; 🇯🇵 Gifu, Japan

Teine Keijinkai Hospital; 🇯🇵 Hokkaido, Japan

Hosp. Quiron Madrid Pozuelo; 🇪🇸 Pozuelo de Alarcon, Spain

Hosp Clinico Univ de Salamanca; 🇪🇸 Salamanca, Spain

Hosp. Univ. Marques de Valdecilla; 🇪🇸 Santander, Spain

Hosp. Virgen Del Rocio; 🇪🇸 Sevilla, Spain

Hosp Univ Fund Jimenez Diaz; 🇪🇸 Madrid, Spain

Hosp. Univ. 12 de Octubre; 🇪🇸 Madrid, Spain

Hosp. Univ. Virgen de La Arrixaca; 🇪🇸 Murcia, Spain

Clinica Univ. de Navarra; 🇪🇸 Pamplona, Spain

Kobe City Medical Center General Hospital; 🇯🇵 Kobe City, Japan

Dokkyo Medical University Saitama Medical Center; 🇯🇵 Koshigaya, Japan

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Japan

National Hospital Organization Matsumoto Medical Center; 🇯🇵 Matsumoto, Japan

National Hospital Organization Okayama Medical Center; 🇯🇵 Okayama, Japan

Japanese Red Cross Osaka Hospital; 🇯🇵 Osaka, Japan

National Hospital Organization Hiroshima-Nishi Medical Center; 🇯🇵 Otake, Japan

Iwate Medical University Hospital; 🇯🇵 Shiwa-gun, Japan

Chonnam National University Hwasun Hospital; 🇰🇷 Jeollanam-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Seoul St Marys Hospital; 🇰🇷 Seoul, Korea, Republic of

VU Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdansk, Poland

Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach; 🇵🇱 Gliwice, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu; 🇵🇱 Poznan, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy; 🇵🇱 Warszawa, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu; 🇵🇱 Wroclaw, Poland

Hosp. Univ. Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hosp Univ Vall D Hebron; 🇪🇸 Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals; 🇪🇸 Barcelona, Spain