Study on the Clinical Efficacy of Teclistamab

NCT06477783 | Recruiting FDA Drug

• 1 other identifier: 64007957MMY4010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 17

Brief Summary

The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.

Conditions

Multiple Myeloma; Hematologic Diseases

Keywords

Teclistamab; Tecvayli; Hematology; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.

  At baseline, monthly until end of study (maximum 24 months)

Secondary Outcomes (8)

• Progression-free survival (PFS)

  At baseline, monthly until end of study (maximum 24 months)

• Overall survival (OS)

  At baseline, monthly until end of study (maximum 24 months)

• Incidence of (serious) adverse events

  At baseline, monthly until end of study (maximum 24 months)

• Depth of response

  At baseline, monthly until end of study (maximum 24 months)

• Time to response (TTR)

  At baseline, monthly until end of study (maximum 24 months)

Study Arms (1)

Relapsed or refractory multiple myeloma patients

Patients aged 18 years or older diagnosed with relapsed or refractory multiple myeloma, who received at least 3 prior lines of treatment. They should be refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody. After confirmation of disease progression, the patients will start treatment with teclistamab per routine clinical care or will have started with teclistamab treatment ≤14 days before intended screening visit

Drug: Teclistamab

Interventions

Teclistamab DRUG

Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.

Also known as: Tecvayli

Relapsed or refractory multiple myeloma patients

Eligibility Criteria

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

Study Population

100 patients with relapsed or refractory multiple myelome who will be treated with teclistamab (Tecvayli®)

You may qualify if:

• Age 18 years or older
• Written informed consent
• Has a diagnosis of relapsed and refractory multiple myeloma
• Has already received at least three previous treatments
• Is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody
• Evidence of disease progression on the last line of therapy, based on determination of response by the IMWG response criteria
• Anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit

You may not qualify if:

• Has participated in a teclistamab trial (teclistamab or control arm) or teclistamab Single Patient Request (SPR) program
• Has started teclistamab treatment \>14 days before intended screening visit.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Janssen Pharmaceutica: collaborator

Study Sites (17)

Imelda

Bonheiden, Antwerpen, 2820, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, 2500, Belgium

RECRUITING

Grand Hôpital de Charleroi

Charleroi, Henegouwen, 6000, Belgium

RECRUITING

EpiCURA

Hornu, Henegouwen, 7301, Belgium

RECRUITING

CHU Ambroise Paré

Mons, Henegouwen, 7000, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

RECRUITING

CHR Citadelle

Liège, Liège, 4000, Belgium

RECRUITING

CHU Liège

Liège, Liège, 4000, Belgium

RECRUITING

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

Algemeen Ziekenhuis Maria Middelares (AZMM)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Gent (UZ Gent)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Vitaz

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

RECRUITING

Institut Jules Bordet

Brussels, Vlaams-Brabant, 1070, Belgium

RECRUITING

UCL Saint Luc

Brussels, Vlaams-Brabant, 1200, Belgium

RECRUITING

AZ Groeninge

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Michel Delforge, MD, PhD

  UZ Leuven Gasthuisberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Delforge, MD, PhD

CONTACT

+32 16 34 68 80; michel.delforge@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 27, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (17)