Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484829
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-21
Brief Title:
Puesta Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
An Open Parallel-Controlled Multicenter Phase IbIIa Clinical Study of the Efficacy and Safety of Puesta Mesylate for Injection in Combination With Pomalidomide Capsules and Low-Dose Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Primary Purpose Phase Ib Determine the maximum tolerated dose MTD of poystat mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM at the recommended phase IIa dose RP2D
Phase IIa To further evaluate the preliminary efficacy of the RP2D dose of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Secondary Objectives Phase Ib
1 to evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma RRMM
2 to evaluate the pharmacokinetic and pharmacodynamic indices after combining fixed-dose pomalidomide capsule and dexamethasone with puesta mesylate for injection in patients with relapsed or refractory multiple myeloma RRMM
3 to observe the efficacy of injectable puesta mesylate combined with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Phase IIa
1 To evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
2 To evaluate the population pharmacokinetic profile of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Phase IIa To further evaluate the preliminary efficacy of the RP2D dose of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Secondary Objectives Phase Ib
1 to evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma RRMM
2 to evaluate the pharmacokinetic and pharmacodynamic indices after combining fixed-dose pomalidomide capsule and dexamethasone with puesta mesylate for injection in patients with relapsed or refractory multiple myeloma RRMM
3 to observe the efficacy of injectable puesta mesylate combined with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Phase IIa
1 To evaluate the safety and tolerability of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
2 To evaluate the population pharmacokinetic profile of puesta mesylate for injection in combination with fixed-dose pomalidomide capsules and dexamethasone in patients with relapsed or refractory multiple myeloma RRMM
Detailed Description:
None
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