Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695508
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2022-11-30
Brief Title:
GMMG-HD10 DSMM-XX 64007957MMY2003 MajesTEC-5
Sponsor:
University of Heidelberg Medical Center
Organization:
University of Heidelberg Medical Center
Study Overview
Official Title:
A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD10DSMMXX
Brief Summary:
Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab- and Talquetamab-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma
OBJECTIVES
The primary objective is to evaluate the safety and tolerability of teclistamab- and talquetamab-based combination regimens over the entire treatment phase for each arm in participants with ND-TEMM
The key secondary objective is to evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments and teclistamab in combination with talquetamab as replacement for HDTASCT following induction
OBJECTIVES
The primary objective is to evaluate the safety and tolerability of teclistamab- and talquetamab-based combination regimens over the entire treatment phase for each arm in participants with ND-TEMM
The key secondary objective is to evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments and teclistamab in combination with talquetamab as replacement for HDTASCT following induction
Detailed Description:
OVERALL DESIGN
130 participants will be enrolled with 10 participants in Arm A 20 participants in Arm A1 20 participants in Arm B 10 participants in Arms C and 10 in C2 20 participants in Arm D 10 participants in each Arm E E1 and optionally F and F1 Cohorts may be further expanded
Arms A A1 B D E E1 F F1 will receive Induction Therapy of 6 cycles 28-days each
Treatment Tec-DRd Arm A A1 Tec-DVRd Arm B Tal-DRd Arms E E1 Tal-DVRd Arms F F1 followed by HDT and a single ASCT according to local SoC treatment Thereafter a Maintenance Therapy of maximum 18 cycles with either Tec-D Arms A A1 B E F or Tal-D E1 F1 is performed
Arm D will receive Tec-DVRd induction followed by 18 cycles Tec-Tal No HDT ASCT will be performed in Arm D
In Arm C and C2 participants will enter the study for maintenance treatment of 18 cycles with Tec-D Arm C or Tal-DR Arm C2 after induction HDT and ASCT according to local SoC outside of the study
Participants will receive maintenance treatment or following induction treatment Arm D 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
130 participants will be enrolled with 10 participants in Arm A 20 participants in Arm A1 20 participants in Arm B 10 participants in Arms C and 10 in C2 20 participants in Arm D 10 participants in each Arm E E1 and optionally F and F1 Cohorts may be further expanded
Arms A A1 B D E E1 F F1 will receive Induction Therapy of 6 cycles 28-days each
Treatment Tec-DRd Arm A A1 Tec-DVRd Arm B Tal-DRd Arms E E1 Tal-DVRd Arms F F1 followed by HDT and a single ASCT according to local SoC treatment Thereafter a Maintenance Therapy of maximum 18 cycles with either Tec-D Arms A A1 B E F or Tal-D E1 F1 is performed
Arm D will receive Tec-DVRd induction followed by 18 cycles Tec-Tal No HDT ASCT will be performed in Arm D
In Arm C and C2 participants will enter the study for maintenance treatment of 18 cycles with Tec-D Arm C or Tal-DR Arm C2 after induction HDT and ASCT according to local SoC outside of the study
Participants will receive maintenance treatment or following induction treatment Arm D 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None