A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

NCT06285318 | Recruiting

• 1 other identifier: 64007957MMY4004
• Study Type: observational
• Target: 900
• Locations: 11 countries
• Sites: 68

Brief Summary

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Outcome Measures

Primary Outcomes (10)

• Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials

  Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.

  Baseline (Day 1)

• Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.

  Up to 40 months

• Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.

  Up to 40 months

• Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.

  Up to 40 months

• Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria.

  Up to 40 months

• Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  Number of participants with MRD negative rate will be assessed.

  Up to 40 months

• Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.

  From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)

• Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first.

  Up to 40 months

• Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

  TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment.

  Up to 40 months

• Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials

  Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported.

  Baseline (Day 1) up to end of treatment (up to 40 months)

Secondary Outcomes (1)

• Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials

  Baseline (Day 1) up to end of treatment (up to 40 months)

Study Arms (4)

Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1

Participants with RRMM who received at least one dose of teclistamab outside of clinical trials on or before 31 December 2022 will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.

Other: Teclistamab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2

Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2023 to 31 December 2024, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.

Other: Teclistamab

Participants with RRMM: Teclistamab Cohort 3

Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2025 to 31 December 2025, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.

Other: Teclistamab

Participants with RRMM: Talquetamab Cohort

Participants with RRMM who received at least one dose of talquetamab outside of clinical trials on or before 31 December 2023 will be enrolled in the study. The data available from the medical records of each enrolled participant will be collected to describe the use of talquetamab.

Other: Talquetamab

Interventions

Teclistamab OTHER

No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

Also known as: TECVAYLI

Participants with RRMM: Teclistamab Cohort 3; Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1; Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2

Talquetamab OTHER

No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

Also known as: TALVEY

Participants with RRMM: Talquetamab Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.

You may qualify if:

• Have a documented diagnosis of multiple myeloma
• Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \& talquetamab can be included in both REALiTEC and REALiTAL cohorts
• Received at least one dose of teclistamab/talquetamab
• Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country/site-specific requirements

You may not qualify if:

• To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial
• To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial
• Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2 and REALiTEC Cohort 3

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (68)

Aalborg Sygehus Syd

Aalborg, 9100, Denmark

RECRUITING

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

COMPLETED

Rigshospitalet

Copenhagen, 2100, Denmark

COMPLETED

Odense University Hospital

Odense, 5000, Denmark

COMPLETED

Sygehus Lillebælt, Vejle

Vejle, 7100, Denmark

RECRUITING

Hopital Albert Calmette - CHU Lille

Lille, 59037, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

COMPLETED

CHU de Nantes hotel Dieu

Nantes, 44000, France

RECRUITING

Hopital Saint Louis

Paris, 75475, France

COMPLETED

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100, France

RECRUITING

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54500, France

COMPLETED

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

COMPLETED

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

COMPLETED

University Hospital Hamburg Eppendorf

Hamburg, 20246, Germany

RECRUITING

Klinikum Region Hannover Klinikum Siloah

Hanover, 30459, Germany

RECRUITING

Uniklinikum Heidelberg 1

Heidelberg, 69120, Germany

COMPLETED

Klinikum Nurnberg Nord

Nuremberg, 90419, Germany

COMPLETED

Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

Würzburg, 97080, Germany

RECRUITING

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

RECRUITING

Laiko General Hospital of Athens

Athens, 115 27, Greece

RECRUITING

Alexandra Hospital

Athens, 115 28, Greece

RECRUITING

University Hospital of Crete, PAGNI

Heraklion, 715 00, Greece

COMPLETED

Ioannina University Hospital

Ioannina, 45500, Greece

RECRUITING

University Hospital Of Larissa

Larissa, 413 34, Greece

RECRUITING

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, 546 39, Greece

RECRUITING

Ahepa University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

RECRUITING

G Papanikolaou Hospital of Thessaloniki

Thessaloniki, 570 10, Greece

RECRUITING

Cork University Hospital

Cork, 00000, Ireland

COMPLETED

Bon Secours Hospital

Cork, T12 DV56, Ireland

COMPLETED

St James Hospital

Dublin, D08 NHY1, Ireland

COMPLETED

Beacon Hospital

Dublin, D18 AK68, Ireland

COMPLETED

University Hospital Galway - Ireland

Galway, H91 YR71, Ireland

COMPLETED

Hadassah Medical Center

Jerusalem, 9112001, Israel

COMPLETED

Sheba Medical Center

Ramat Gan, 52621, Israel

COMPLETED

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

COMPLETED

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

COMPLETED

Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

Bolzano, 39100, Italy

COMPLETED

Ospedale A.Perrino di Brindisi

Brindisi, 72100, Italy

COMPLETED

AOU Careggi

Florence, 50141, Italy

COMPLETED

Ospedale Vito Fazzi

Lecce, 73100, Italy

COMPLETED

Policlinico di Milano

Milan, 20121, Italy

COMPLETED

IRCCS Istituto Europeo di Oncologia

Milan, 20252, Italy

COMPLETED

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

COMPLETED

Casa di Cura La Maddalena

Palermo, 90146, Italy

COMPLETED

Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

Roma, 00168, Italy

COMPLETED

Presidio Ospedaliero Santo Spirito in Sassia

Roma, 65124, Italy

COMPLETED

Ospedale Andrea Tortora Pagani Salerno

Salerno, 84098, Italy

COMPLETED

Ospedale Ca' Foncello

Treviso, 31100, Italy

COMPLETED

Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore

Trieste, 34128, Italy

COMPLETED

Ospedale Castelli

Verbania, 28922, Italy

COMPLETED

Ospedale San Bortolo

Vicenza, 36100, Italy

COMPLETED

Akershus Universitetssykehus

Oslo, 1478, Norway

RECRUITING

Vestfold Hospital Trust

Tønsberg, 3103, Norway

RECRUITING

Hosp. Ntra. Sra. de Sonsoles

Ávila, 05071, Spain

RECRUITING

Hosp. Univ. Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

RECRUITING

Hosp. Univ. de La Paz

Madrid, 28046, Spain

RECRUITING

Hosp. Costa Del Sol

Málaga, 29603, Spain

COMPLETED

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

RECRUITING

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Länssjukhuset Ryhov

Jönköping, 551 85, Sweden

COMPLETED

Karolinska Universitetssjukhuset

Stockholms, 12559, Sweden

RECRUITING

Uddevalla Hospital

Uddevalla, 451 98, Sweden

COMPLETED

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

RECRUITING

University College Hospital

London, NW1 2PG, United Kingdom

RECRUITING

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

COMPLETED

The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

talquetamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen-Cilag Limited Clinical Trial

  Janssen-Cilag Limited

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 29, 2024
• Study Start: December 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5); DE (7); IL (3); IT (16); FR (6); GB (4); SE (4); GR (9); IE (5); NO (2); ES (7)