Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07569757
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2934 injection — DRUG
    TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
  • Pomalidomide Capsule — DRUG
    Pomalidomide capsules are an immunomodulatory(IMiD).
  • Selinexor tablets — DRUG
    Selinexor is a selective nuclear export protein inhibitor.
  • Dexamethasone tablets — DRUG
    Dexamethasone tablets are a type of adrenocortical hormone drug.

Study Details

This study is a randomized, open-label, multicenter Phase III clinical trial involving patients with relapsed/refractory multiple myeloma. The estimated total sample size is 260 cases, who will be randomly assigned in a 1:1 ratio to the test group and the control group. The primary objective of the study is to demonstrate the efficacy of TQB2934 for injection compared to the investigator-selected regimen in subjects with relapsed or refractory multiple myeloma (RRMM) by evaluating progression-free survival (PFS).

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2934 injection
    TQB2934 injection, 28 days as a treatment cycle.
  • Active Comparator: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
    Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Baseline up to 5 years ]

Central Contacts

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