Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348108
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
Sponsor:
Thomas Martin MD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase Ib Multi-center Study of Talquetamab in Combination With Iberdomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety side effects and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement relapsed or has not responded to previous treatment refractory There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma RRMM who are triple class refractory and have been exposed to B-cell maturation antibody BCMA targeted therapy These patients currently have limited treatment options and poor survival Talquetamab is approved for use by the Food and Drug Administration FDA to treat RRMM when given alone Talquetamab can bring T-cells to the myeloma cell resulting in myeloma cell death Iberdomide is an investigational drug Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive Dexamethasone is a corticosteroid is similar to a natural hormone produced by the adrenal glands It relieves inflammation swelling heat redness and pain and is used to treat certain types of cancer including myeloma Giving talquetamab in combination with iberdomide and dexamethasone may be safe tolerable and effective in treating patients with RRMM
Detailed Description:
PRIMARY OBJECTIVES
I To assess safety of the combination of talquetamab Tal iberdomide Iber and dexamethasone Dex in patients with triple class exposed TCE RRMM Phase 1b-dose escalation DE
II To assess dose limiting toxicity DLT and determine the recommended phase 2 dose RP2D of the combination of Tal Iber and Dex administered in 28-day cycles in patients with TCE RRMM Phase 1b-DE III To further assess safety of RP2D of the combination of Tal Iber and Dex administered in 28-day cycles in patients with TCE RRMM Len-refractory and having received 2 prior lines of therapy Phase 1b-expansion Exp IV To assess overall response rate ORR in patients with TCE RRMM Len-refractory and having received 2 prior lines of therapy Phase 1b-Exp
SECONDARY OBJECTIVES
I To assess ORR and to determine minimal residual disease MRD negative - rates in patients achieving very good partial remission VGPR
II To assess toxicity incidence of adverse events AEs serious AEs SAEs and treatment discontinuation due to toxicity and safety physical examination findings vital signs and clinical laboratory evaluations in patients with RRMM
III Describe changes in health-related quality of life HRQoL using the European Organization for Research and Treatment of Cancer C30 -Quality of Life questionnaire QLQ EORTC-QLQ-C30 and EORTC QLQ-Multiple Myeloma Questionnaire MY20
EXPLORATORY OBJECTIVES
I To assess serial cytokines levels with treatment of the combination of Tal Iber and Dex and predictive values of response cytokine release syndrome CRS and other adverse events
II To assess changes in immune cells in blood and bone marrow with treatment of the combination of Tal Iber and Dex
III To determine the efficacy of combination of Tal Iber and Dex defined as achieving complete response CR and MRD - status and correlation between mass spectroscopy and bone marrow BM MRD assessments
OUTLINE This is a dose-escalation study of Iber followed by a dose-expansion study
Patients receive Tal subcutaneous SQ over 1-3 minutes on days 1 4 8 and 15 of cycle 1 days 1 and 15 of cycles 2-6 and day 1 of cycle 7 and subsequent cycles Iber orally PO once daily QD on days -7 thru day 14 of cycle 1 and days 1-21 of cycle 2 and subsequent cycles and Dex PO on days 1 4 8 15 and 22 of cycle 1 and on days 1 8 15 and 22 of cycles 2-4 but may be continued at the discretion of the investigator Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow biopsy skeletal x-ray computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI tissue and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days every 8 weeks for up to 2 years or until progression or initiation of subsequent therapy
I To assess safety of the combination of talquetamab Tal iberdomide Iber and dexamethasone Dex in patients with triple class exposed TCE RRMM Phase 1b-dose escalation DE
II To assess dose limiting toxicity DLT and determine the recommended phase 2 dose RP2D of the combination of Tal Iber and Dex administered in 28-day cycles in patients with TCE RRMM Phase 1b-DE III To further assess safety of RP2D of the combination of Tal Iber and Dex administered in 28-day cycles in patients with TCE RRMM Len-refractory and having received 2 prior lines of therapy Phase 1b-expansion Exp IV To assess overall response rate ORR in patients with TCE RRMM Len-refractory and having received 2 prior lines of therapy Phase 1b-Exp
SECONDARY OBJECTIVES
I To assess ORR and to determine minimal residual disease MRD negative - rates in patients achieving very good partial remission VGPR
II To assess toxicity incidence of adverse events AEs serious AEs SAEs and treatment discontinuation due to toxicity and safety physical examination findings vital signs and clinical laboratory evaluations in patients with RRMM
III Describe changes in health-related quality of life HRQoL using the European Organization for Research and Treatment of Cancer C30 -Quality of Life questionnaire QLQ EORTC-QLQ-C30 and EORTC QLQ-Multiple Myeloma Questionnaire MY20
EXPLORATORY OBJECTIVES
I To assess serial cytokines levels with treatment of the combination of Tal Iber and Dex and predictive values of response cytokine release syndrome CRS and other adverse events
II To assess changes in immune cells in blood and bone marrow with treatment of the combination of Tal Iber and Dex
III To determine the efficacy of combination of Tal Iber and Dex defined as achieving complete response CR and MRD - status and correlation between mass spectroscopy and bone marrow BM MRD assessments
OUTLINE This is a dose-escalation study of Iber followed by a dose-expansion study
Patients receive Tal subcutaneous SQ over 1-3 minutes on days 1 4 8 and 15 of cycle 1 days 1 and 15 of cycles 2-6 and day 1 of cycle 7 and subsequent cycles Iber orally PO once daily QD on days -7 thru day 14 of cycle 1 and days 1-21 of cycle 2 and subsequent cycles and Dex PO on days 1 4 8 15 and 22 of cycle 1 and on days 1 8 15 and 22 of cycles 2-4 but may be continued at the discretion of the investigator Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow biopsy skeletal x-ray computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI tissue and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days every 8 weeks for up to 2 years or until progression or initiation of subsequent therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01992 | REGISTRY | NCI Clinical Trials Reporting Program | None |