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

NCT ID: NCT07138209

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed or Refractory Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLS32015

Participants will receive teclistamab monotherapy.

Group Type EXPERIMENTAL

QLS32015

Intervention Type DRUG

QLS32015 will be administered subcutaneously.

Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)

Participants will receive either Pd or Sd based on principal investigator's choice.

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

Pomalidomide will be administered orally.

Selinexor

Intervention Type DRUG

Selinexor will be administered orally.

Dexamethasone

Intervention Type DRUG

Dexamethasone will be administered orally

Interventions

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QLS32015

QLS32015 will be administered subcutaneously.

Intervention Type DRUG

Pomalidomide

Pomalidomide will be administered orally.

Intervention Type DRUG

Selinexor

Selinexor will be administered orally.

Intervention Type DRUG

Dexamethasone

Dexamethasone will be administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years old, regardless of gender.
* Subjects should be willing and able to comply with the study schedule and protocols.
* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.
* Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).

Exclusion Criteria

* Known hypersensitivity to any of the ingredients of this product.
* Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
* Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
* Disease is considered refractory to pomalidomide and selinexor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Gang An, Professor

Role: CONTACT

008613502181109

Other Identifiers

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QLS32015-301

Identifier Type: -

Identifier Source: org_study_id

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