RecruitingPhase 2NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma

Sponsor

University Hospital, Lille

Enrollment

74 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment including teclistamab (an immunotherapy that targets myeloma cells) for elderly patients newly diagnosed with multiple myeloma who are not candidates for a stem cell transplant. Multiple myeloma is a cancer of plasma cells in the bone marrow. **You may be eligible if...** - You are 65 or older - You have been newly diagnosed with multiple myeloma - Your disease has measurable markers in your blood or urine - You are not considered a good candidate for high-dose chemotherapy and stem cell transplant - You have an ECOG performance score of 0–2 (relatively functional) **You may NOT be eligible if...** - You have already received treatment for multiple myeloma - Your organ function does not meet the lab criteria - You have other serious health 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

DRUGTeclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

DRUGDaratumumab

Daratumumab will be administered via a subcutaneous injection (SC)

DRUGLenalidomide

Lenalidomide will be administered orally

Locations(29)

Chu Amiens - Hopital Sud

Amiens, France

Chru Angers

Angers, France

Ch D'Avignon

Avignon, France

Centre Hospitalier de La Cote Basque

Bayonne, France

Chu de Besancon

Besançon, France

Aphp Hopital Avicenne

Bobigny, France

Chu de Caen

Caen, France

Chu Dijon Bourgogne

Dijon, France

Ch de Dunkerque

Dunkirk, France

Chu de Grenoble

La Tronche, France

Centre Hospitalier de Versailles

Le Chesnay, France

Chu de Lille, Hopital Claude Huriez

Lille, France

Chu Limoges

Limoges, France

Centre Leon Berard

Lyon, France

Chr Metz-Thionville

Metz, France

Chu Montpellier

Montpellier, France

Hopital E. Muller- Ghrmsa

Mulhouse, France

Chru de Nancy, Hopitaux de Brabois

Nancy, France

Chu de Nantes Site Hotel Dieu

Nantes, France

Aphp - Chu Henri Mondor

Paris, France

Aphp - Hopital Saint Antoine

Paris, France

Aphp - Hopital Saint Louis

Paris, France

Chu Bordeaux

Pessac, France

Chu de Poitiers

Poitiers, France

Chu de Reims

Reims, France

Chu Pontchaillou

Rennes, France

Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

Strasbourg, France

Oncopole Chu Toulouse

Toulouse, France

Chru Bretonneau

Tours, France

View Full Details on ClinicalTrials.gov

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NCT05572229

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