NCT07138209

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P25-P50 for phase_3

Timeline
44mo left

Started Nov 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Nov 2025Dec 2029

First Submitted

Initial submission to the registry

August 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 7, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

August 13, 2025

Last Update Submit

February 25, 2026

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS)

    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.

    Up to 4 years

Secondary Outcomes (7)

  • Overall Response (Partial Response [PR] or Better)

    Up to 4 years

  • Very Good Partial Response (VGPR) or Better Response

    Up to 4 years

  • Complete Response (CR) or Better Response

    Up to 4 years

  • Duration of Response (DOR)

    Up to 4 years

  • Minimal Residual Disease (MRD) Negativity

    Up to approximately 4 years

  • +2 more secondary outcomes

Study Arms (2)

QLS32015

EXPERIMENTAL

Participants will receive teclistamab monotherapy.

Drug: QLS32015

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

EXPERIMENTAL

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

Drug: PomalidomideDrug: SelinexorDrug: Dexamethasone

Interventions

QLS32015DRUG

QLS32015 will be administered subcutaneously.

QLS32015
PomalidomideDRUG

Pomalidomide will be administered orally.

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

Selinexor will be administered orally.

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

Dexamethasone will be administered orally

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Clinical Research Center for Blood Diseases

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

RecurrenceMultiple Myeloma

Interventions

pomalidomideselinexorDexamethasone

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Gang An, Professor

CONTACT

008613502181109angang@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 22, 2025

Study Start

November 7, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

CN(1)