Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05849610
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-02-24
Brief Title:
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
An Open Label Multicenter Phase 2 Pilot Study Evaluating Early Treatment With Bispecific T-cell Redirectors Teclistamab and Talquetamab in the Frontline Therapy of Newly Diagnosed High-risk Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2023-10
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:
GEM-TECTAL
Brief Summary:
The goal of this Phase 2 open-label multicenter non-randomized pilot study is to evaluate the efficacy in terms of MRD negative CR rate after Intensification therapy and safety of Tec-Dara TeclistamabDaratumumab and Tal-Dara TalquetamabDaratumumab in de novo high-risk multiple myeloma DNHRMM patients
Detailed Description:
A total of 30 transplant eligible or elderly fit patients with high risk multiple myeloma will be enrolled
1 Patients will receive a 4-cycle DaraVRD daratumumab bortezomib lenalidomide dexamethasone INDUCTION therapy Cycles will be of 28 days 4-week cycles in duration for daratumumab and for VRD
After the 4-cycle Induction all patients will receive the 1st INTENSIFICATION treatment which consists of 6 cycles of Tec-Dara Cycles will be of 28 days 4-week cycles in duration for daratumumab and for teclistamab
1st Intsensification patients will receive a 6-cycle DaraTeclistamab
2 At the end of 1st Intensification timepoint treatments depends on MRD status
21 MRD negative patients in CR at the end of Intensification will receive MAINTENANCE therapy with Tec-Dara continuously for 2 years Cycles will be of 28-days in duration for Tec-Dara Teclistamab SC and daratumumab SC
22 MRD positive patients or patients who didnt achieve CR despite MRD negativity will have EARLY RESCUE INTERVENTION ERI with Tal-Dara for 6 cycles MRD and response will be evaluated again after 6 cycles treatment with Tal-Dara MRD negative patients in CR will receive continuous treatment with Tal-Dara for 2 years
221 Early Rescue Intervention with Tal-Dara Patients who are MRD after intensification or who convert from MRD negative into positive or experience a relapse from CR without fulfilling criteria for disease progression at any time during Tec-Dara treatment will have ERI with Tal-Dara Cycles will be of 28 days in duration
222 MRD negative patients in CR will receive continuous treatment with Tal-Dara for 2 years Cycles will be of 28-days of duration for Tal-Dara
4 SALVAGE therapy If the patient remains MRD or doesnt achieve CR despite MRD negativity after 6 cycles of ERI with Tal-Dara or has disease progression at any time further treatment will be offered as per the investigation decision outside of the study
1 Patients will receive a 4-cycle DaraVRD daratumumab bortezomib lenalidomide dexamethasone INDUCTION therapy Cycles will be of 28 days 4-week cycles in duration for daratumumab and for VRD
After the 4-cycle Induction all patients will receive the 1st INTENSIFICATION treatment which consists of 6 cycles of Tec-Dara Cycles will be of 28 days 4-week cycles in duration for daratumumab and for teclistamab
1st Intsensification patients will receive a 6-cycle DaraTeclistamab
2 At the end of 1st Intensification timepoint treatments depends on MRD status
21 MRD negative patients in CR at the end of Intensification will receive MAINTENANCE therapy with Tec-Dara continuously for 2 years Cycles will be of 28-days in duration for Tec-Dara Teclistamab SC and daratumumab SC
22 MRD positive patients or patients who didnt achieve CR despite MRD negativity will have EARLY RESCUE INTERVENTION ERI with Tal-Dara for 6 cycles MRD and response will be evaluated again after 6 cycles treatment with Tal-Dara MRD negative patients in CR will receive continuous treatment with Tal-Dara for 2 years
221 Early Rescue Intervention with Tal-Dara Patients who are MRD after intensification or who convert from MRD negative into positive or experience a relapse from CR without fulfilling criteria for disease progression at any time during Tec-Dara treatment will have ERI with Tal-Dara Cycles will be of 28 days in duration
222 MRD negative patients in CR will receive continuous treatment with Tal-Dara for 2 years Cycles will be of 28-days of duration for Tal-Dara
4 SALVAGE therapy If the patient remains MRD or doesnt achieve CR despite MRD negativity after 6 cycles of ERI with Tal-Dara or has disease progression at any time further treatment will be offered as per the investigation decision outside of the study
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