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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: QLS32015; Drug: Pomalidomide; Drug: Selinexor

Study type: Interventional

Funder types: Industry

Identifiers

NCT07138209

QLS32015-301

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

QLS32015

Experimental group

Description:

Participants will receive teclistamab monotherapy.

Treatment:

Drug: QLS32015

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

Experimental group

Description:

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

Treatment:

Drug: Selinexor

Drug: Pomalidomide

Drug: Dexamethasone