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Hematological MalignanciesPhase 2MonumenTAL-1NCT04634552

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

A Phase 2 study testing Talquetamab in people with Hematological Malignancies, run by Janssen Research & Development, LLC at 78 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Malignancies
What is being tested?
Talquetamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
78 sitesin 11 countries
Study dates
1 Feb 2021to 30 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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; Cohort E: Multiple myeloma must be measurable by local 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

Who cannot join

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: 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)

Trial locations and contacts

78 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

78 sites in 11 countries

United States14 sites, 9 recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

    Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Completed

  • City of Hope

    Duarte, California, 91010

    Completed

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Completed

  • NYU Langone Health

    New York, New York, 10016

    Active, not recruiting

  • Mount Sinai Medical Center

    New York, New York, 10023

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Completed

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Japan13 sites

  • Kameda Medical Center

    Chiba, 296-8602

    Completed

  • Fukuoka University Hospital

    Fukuoka, 814-0180

    Completed

  • Ogaki Municipal Hospital

    Gifu, 503-8502

    Completed

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555

    Completed

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

    Completed

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

    Completed

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Completed

  • Kurashiki Central Hospital

    Kurashiki, 710-8602

    Completed

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701

    Completed

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Completed

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555

    Completed

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, 739-0696

    Active, not recruiting

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

    Completed

Other trials in Japan

Spain11 sites, 5 recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

    Completed

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 8908

    Active, not recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

    Completed

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Active, not recruiting

  • Hosp. Univ. Virgen de La Arrixaca

    Murcia, 30120

    Active, not recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

    Completed

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

China8 sites

  • Peking University Third Hospital

    Beijing, 100191

    Completed

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Active, not recruiting

  • The 1st Affiliated Hospital Of Medical College Zhejiang University 1

    Hangzhou, 310003

    Active, not recruiting

  • The 1St Affiliated Hospital of Medical College Zhejiang University

    Hangzhou, 310003

    Active, not recruiting

  • First Affiliated Hospital SooChow University

    Suzhou, 215006

    Active, not recruiting

  • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

    Tianjin, 300320

    Active, not recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

    Completed

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710063

    Completed

Other trials in China

France6 sites

  • CHU Henri Mondor

    Créteil, 94000

    Active, not recruiting

  • Hospices Civils de Lyon HCL

    Lyon, 69002

    Active, not recruiting

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

    Active, not recruiting

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

    Active, not recruiting

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

    Active, not recruiting

  • Pôle IUC Oncopole CHU

    Toulouse, 31059

    Active, not recruiting

Other trials in France

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Completed

  • Seoul National University Hospital

    Seoul, 03080

    Completed

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Completed

  • Asan Medical Center

    Seoul, 05505

    Completed

  • Samsung Medical Center

    Seoul, 06351

    Completed

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Completed

Other trials in South Korea

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

    Active, not recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Active, not recruiting

  • Hadassah Medical Center

    Jerusalem, 91120

    Active, not recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Active, not recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Active, not recruiting

Other trials in Israel

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

    Active, not recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    Gliwice, 44102

    Completed

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

    Active, not recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

    Completed

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

    Active, not recruiting

Other trials in Poland

Belgium4 sites

  • UZ Antwerpen

    Edegem, 2650

    Completed

  • UZ Leuven

    Leuven, 3000

    Active, not recruiting

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

    Active, not recruiting

  • UCL - Saint Luc

    Woluwe-Saint-Lambert, 1200

    Completed

Other trials in Belgium

Germany4 sites

  • Charite Campus Benjamin Franklin

    Berlin, 12203

    Active, not recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Active, not recruiting

  • Universitaetsklinikum Muenster

    Münster, 48149

    Completed

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

    Active, not recruiting

Other trials in Germany

Netherlands2 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

    Completed

  • UMCU

    Utrecht, 3584 CX

    Completed

Other trials in Netherlands

About this study

Official title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

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).

Being tested
Talquetamab
Keywords
Multiple Myeloma
Medical subject headings
Hematologic Neoplasms, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered SC until disease progression.

Study groups in NCT04634552
Study groupRoleWhat they receive
Part 3: Cohort A (Talquetamab)ExperimentalCohort 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. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.
Receives: Drug: Talquetamab
Part 3: Cohort B (Talquetamab)ExperimentalCohort 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. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Receives: Drug: Talquetamab
Part 3: Cohort C (Talquetamab)ExperimentalCohort 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. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Receives: Drug: Talquetamab
Part 3: Cohort D (Talquetamab)ExperimentalCohort 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 upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Receives: Drug: Talquetamab
Part 3: Cohort E (Talquetamab)ExperimentalCohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. 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 will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
Receives: Drug: Talquetamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    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.

    Measured: Up to 2 years and 10 months

Secondary outcomes (18)

  1. Duration of Response (DOR)

    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.

    Measured: Up to 2 years and 10 months

  2. Very Good Partial Response (VGPR) or Better Rate

    VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

    Measured: Up to 2 years and 10 months

  3. Complete Response (CR) or Better Rate

    CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.

    Measured: Up to 2 years and 10 months

  4. Stringent Complete Response (sCR) Rate

    sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.

    Measured: Up to 2 years and 10 months

  5. Time to Response (TTR)

    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.

    Measured: Up to 2 years and 10 months

  6. Progression-Free Survival (PFS)

    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.

    Measured: Up to 2 years and 10 months

  7. Overall Survival (OS)

    OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

    Measured: Up to 2 years and 10 months

  8. Minimal Residual Disease (MRD) Negative Rate

    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.

    Measured: Up to 2 years and 10 months

  9. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    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.

    Measured: Up to 2 years and 10 months

  10. Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

    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.

    Measured: Up to 2 years and 10 months

  11. Number of Participants with AEs by Severity

    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.

    Measured: Up to 2 years and 10 months

  12. Number of Participants with Abnormalities in Clinical Laboratory Values

    Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.

    Measured: Up to 2 years and 10 months

  13. Serum Concentration of Talquetamab

    Serum samples will be analyzed to determine concentrations of talquetamab.

    Measured: Up to 2 years and 10 months

  14. Number of Participants with Talquetamab Antibodies

    Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.

    Measured: Up to 2 years and 10 months

  15. 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)

    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.

    Measured: Baseline up to 2 years and 10 months

  16. Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)

    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.

    Measured: Baseline up to 2 years and 10 months

  17. Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)

    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).

    Measured: Baseline up to 2 years and 10 months

  18. Overall Response Rate (ORR) in Participants with High-risk Molecular Features

    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.

    Measured: Up to 2 years and 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start1 Feb 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634552
Sponsor's protocol ID
CR108920
Other IDs
TALMMY1001-PT3, 2017-002400-26, 2023-504581-29-00, 2023, 2017
Acronym
MonumenTAL-1
Status last verified
Sep 2026
First submitted
16 Nov 2020
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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
Expanded access
Available

Publications

  • Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Cortes-Selva D, Masterson T, Khedkar S, Tolbert J, Kane C, Saber I, Heuck C, Chari A. Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma. Future Oncol. 2026 Sep 28:1-16. doi: 10.1080/14796694.2026.2722559. Online ahead of print.

    PubMed 42803498

  • Chari A, Touzeau C, Berdeja JG, Oriol A, van de Donk NW, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Masterton T, Tolbert J, Renaud T, Kane C, Heuck C, Moreau P. Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study. Future Oncol. 2026 Aug 30:1-20. doi: 10.1080/14796694.2026.2709901. Online ahead of print.

    PubMed 42669079

  • Rasche L, Schinke C, Touzeau C, Minnema MC, van de Donk N, Rodriguez-Otero P, Mateos MV, Ye JC, Tomlinson C, Vishwamitra D, Singh I, Qin X, Campagna M, Masterson T, Vreys V, Lau BW, Tolbert J, Renaud T, Heuck C, Chari A. Talquetamab in patients with relapsed/refractory multiple myeloma: 3-year follow-up of the phase 1/2 MonumenTAL-1 study. Blood. 2026 Aug 6:blood.2025031994. doi: 10.1182/blood.2025031994. Online ahead of print.

    PubMed 42561120

  • Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Moreau P, San-Miguel J, Rodriguez-Otero P, Kato K, Bathija S, Katz EG, Masterson T, Tomlinson C, Chari A. A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study. Future Oncol. 2026 Jun;22(14):1651-1668. doi: 10.1080/14796694.2026.2669331. Epub 2026 Jun 16.

    PubMed 42299486

  • Ito S, Kuroda Y, Sunami K, Matsue K, Imada K, Tamura H, Fujikawa E, Yamazaki H, Takamoto M, Pei L, Qin X, Masterson TJ, Campagna M, Vreys V, Lau BW, Takamatsu Y. Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study. Int J Hematol. 2026 Apr;123(4):580-592. doi: 10.1007/s12185-025-04134-6. Epub 2025 Dec 17.

    PubMed 41405810

  • Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.

    PubMed 41313549

  • van de Donk NWCJ, Chari A, Martin T, Krishnan A, Rasche L, Ye JC, Popat R, Lipe B, Rodriguez C, Schinke C, Skerget S, Vishwamitra D, Verona R, Gong J, Singh I, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Smit MD, Heuck C, Mateos MV. Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma. Cancer Med. 2025 Oct;14(19):e71276. doi: 10.1002/cam4.71276.

    PubMed 41036677

  • Schinke C, Rodriguez-Otero P, van de Donk NWCJ, Lipe B, Lavi N, Rasche L, Parekh S, Van Oekelen O, Vishwamitra D, Skerget S, Cortes-Selva D, Verona R, Hilder B, Masterson T, Campagna M, Khedkar S, Renaud T, Tolbert J, Kane C, Gray KS, Saber I, Heuck C, Chari A. Infections and parameters of humoral immunity with talquetamab in relapsed/refractory multiple myeloma in MonumenTAL-1. Blood Adv. 2025 Nov 25;9(22):5752-5762. doi: 10.1182/bloodadvances.2025016613.

    PubMed 40864183

  • Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Qin X, Kato K, Bathija S, Katz EG, Gries KS, Campagna M, Masterson T, Hilder BW, Tolbert J, Renaud T, Heuck C, Tomlinson C, Moreau P, San-Miguel J, Rodriguez-Otero P, Chari A. Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study. Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.

    PubMed 40631904

  • Chari A, Touzeau C, Schinke C, Minnema MC, Berdeja JG, Oriol A, van de Donk NWCJ, Rodriguez-Otero P, Morillo D, Martinez-Chamorro C, Mateos MV, Costa LJ, Caers J, Rasche L, Krishnan A, Ye JC, Karlin L, Lipe B, Vishwamitra D, Skerget S, Verona R, Ma X, Qin X, Ludlage H, Campagna M, Masterson T, Hilder B, Tolbert J, Renaud T, Goldberg JD, Kane C, Heuck C, San-Miguel J, Moreau P. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025 Apr;12(4):e269-e281. doi: 10.1016/S2352-3026(24)00385-5. Epub 2025 Mar 13.

    PubMed 40090350

  • Catamero D, Ray C, Purcell K, Leahey S, Esler E, Rogers S, Hefner K, O'Rourke L, Gray K, Tolbert J, Renaud T, Patel S, Hannemann L, Shenoy S. Nursing Considerations for the Clinical Management of Adverse Events Associated with Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma. Semin Oncol Nurs. 2024 Oct;40(5):151712. doi: 10.1016/j.soncn.2024.151712. Epub 2024 Aug 17.

    PubMed 39155155

  • Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talquetamab in people with Hematological Malignancies, run by Janssen Research & Development, LLC at 78 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Japan, Spain, China, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 2 years and 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04634552, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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