GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 — HD10/DSMMXX  

Multiple Myeloma Clinical Trial

Official title: A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab in Combination With Daratumumab, Lenalidomide, and Dexamethasone With or Without Bortezomib as Induction Therapy and Teclistamab in Combination With Daratumumab and Lenalidomide as Maintenance Therapy in Participants With Newly Diagnosed Transplant Eligible Multiple Myeloma

Status Recruiting

Clinical Trial Summary

A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab in Combination with Daratumumab, Lenalidomide, and Dexamethasone with or without Bortezomib as Induction Therapy and Teclistamab in Combination with Daratumumab and Lenalidomide as Maintenance Therapy in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma.

OBJECTIVES:

The primary objective is to evaluate the safety and tolerability of Tec-DRd and Tec-DVRd as induction therapy and Tec-DR as post-transplant maintenance therapy in participants with ND-TEMM.

The key secondary objective is to evaluate the efficacy of Tec-DRd and Tec-DVRd as induction therapy and Tec-DR as post-transplant maintenance therapy.

Clinical Trial Description

OVERALL DESIGN:

70 participants will be enrolled with approximately 10 participants in Arm A, 10 participants in Arm C, 40 participants in Arm A1 and Arm B (20 each Arm), and optionally 10 further participants in Arm C1

Arms A, A1 and B will receive Induction Therapy of 6 cycles (28-days each):

Treatment: Tec-DRd (Arm A, A1) or Tec-DVRd (Arm B) followed by HDT and a single ASCT according to local SoC treatment. Thereafter a Maintenance Therapy of maximum 18 cycles with Tec-DR is performed.

In Arm C and C1 participants will enter the study for maintenance treatment of 18 cycles with Tec-DR, after induction, HDT and ASCT according to local SoC (outside of the study).

Participants will receive maintenance treatment with Tec-DR for a maximum of 18 cycles or until confirmed progressive disease, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. An optional end of treatment is possible for patients who have 12 months sustained MRD negativity.

Periodic safety evaluations will be conducted to ensure that treatment is safe and tolerable. Upon treatment discontinuation, an EOT Visit will be conducted. Thereafter, the participant will continue in the Follow-up Phase until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT05695508
• Study type: Interventional
• Source: University of Heidelberg Medical Center
• Contact: Marc S Raab, Prof. Dr. med
• Phone: +49 6221 56
• Email: s.gmmg@med.uni-heidelberg.de
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Completion date: October 15, 2027