RecruitingPhase 2NCT06505369

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

A Phase II Study Measuring MRD Negativity After Bispecific T-cell Redirectors Talquetamab and Teclistamab Consolidation in Sequence as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients


Sponsor

North Estonia Medical Centre

Enrollment

50 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment approach for newly diagnosed multiple myeloma (a cancer of plasma cells in the bone marrow) in patients who are eligible for a stem cell transplant. It combines standard transplant preparation with bispecific T-cell engagers — a new type of immunotherapy that helps the immune system identify and kill myeloma cells. **You may be eligible if...** - You have newly diagnosed multiple myeloma confirmed by standard criteria - You are eligible for high-dose therapy and stem cell transplant - You are in reasonably good health (ECOG score ≤2) - If HIV-positive: your viral load is undetectable and you are on stable HIV therapy - You are willing and able to follow the study requirements **You may NOT be eligible if...** - You have previously been treated for multiple myeloma - You are not eligible for stem cell transplant - You are pregnant or not willing to use adequate contraception - You have uncontrolled serious infections or medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Daratumumab will be administered by SC injection

DRUGBortezomib

Bortezomib will be administered by SC injection

DRUGLenalidomide

Lenalidomide will be administered by oral route

DRUGDexamethasone

Dexamethasone will be administered by oral route

DRUGTalquetamab

Talquetamab will be administered by SC injection

DRUGTeclistamab

Teclistamab will be administered by SC injection


Locations(7)

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Vejle hospital

Vejle, Denmark

North Estonia Medical Centre

Tallinn, Estonia

Oslo University Hospital, Oslo Myeloma Centre

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

St. Olavs Hospital

Trondheim, Norway

View Full Details on ClinicalTrials.gov

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NCT06505369


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