A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07138209
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QLS32015 — DRUG
    QLS32015 will be administered subcutaneously.
  • Pomalidomide — DRUG
    Pomalidomide will be administered orally.
  • Selinexor — DRUG
    Selinexor will be administered orally.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally

Study Details

The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd/Sd for the treatment of relapsed or refractory multiple myeloma.

Key Dates

Start date
Nov 7, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: QLS32015
    Participants will receive teclistamab monotherapy.
  • Experimental: Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)
    Participants will receive either Pd or Sd based on principal investigator's choice.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 4 years ]

Central Contacts

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