Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07138209

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Relapsed or Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Clinical Research Center for Blood Diseases

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Qirou Wang

CONTACT

[email protected]

86 022 23608025

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 0.5 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.

Treatment and study plan

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

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to 4 years

    PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Overall Response (Partial Response [PR] or Better)

    Time frame: Up to 4 years

    Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.

  2. Very Good Partial Response (VGPR) or Better Response

    Time frame: Up to 4 years

    VGPR or better (Stringent Complete Response [sCR]+Complete Response [CR]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria.

  3. Complete Response (CR) or Better Response

    Time frame: Up to 4 years

    CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria

  4. Duration of Response (DOR)

    Time frame: Up to 4 years

    DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever

  5. Minimal Residual Disease (MRD) Negativity

    Time frame: Up to approximately 4 years

    MRD negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy

  6. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 4 years

    Number of participants with AEs by Severity will be reported.

  7. Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)

    Time frame: Baseline up to 4 years

    Change from baseline scores

Study contacts

Contact information is provided by the study sponsor or research team.

Gang An, Professor

CONTACT

[email protected]

008613502181109

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 22, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.