Relapsed or Refractory Multiple MyelomaPhase 3NCT07138209
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 study testing QLS32015, Pomalidomide and Selinexor in people with Relapsed or Refractory Multiple Myeloma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- QLS32015, Pomalidomide and Selinexor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2025to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Clinical Research Center for Blood Diseases
Tianjin, Tianjin Municipality
Qirou Wang, 86 022 23608025, ec@ihcams.ac.cn
About this study
Official 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
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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- QLS32015, Pomalidomide, Selinexor, Dexamethasone
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS32015Drug
QLS32015 will be administered subcutaneously.
PomalidomideDrug
Pomalidomide will be administered orally.
SelinexorDrug
Selinexor will be administered orally.
DexamethasoneDrug
Dexamethasone will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| QLS32015 | Experimental | Participants will receive teclistamab monotherapy. Receives: Drug: QLS32015 |
| Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd) | Experimental | Participants will receive either Pd or Sd based on principal investigator's choice. Receives: Drug: Pomalidomide; Drug: Selinexor; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
Secondary outcomes (7)
Overall Response (Partial Response [PR] or Better)
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.
Measured: Up to 4 years
Very Good Partial Response (VGPR) or Better Response
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.
Measured: Up to 4 years
Complete Response (CR) or Better Response
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
Measured: Up to 4 years
Duration of Response (DOR)
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
Measured: Up to 4 years
Minimal Residual Disease (MRD) Negativity
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
Measured: Up to approximately 4 years
Number of Participants with Adverse Events (AEs) by Severity
Number of participants with AEs by Severity will be reported.
Measured: Up to 4 years
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)
Change from baseline scores
Measured: Baseline up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start7 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138209
- Sponsor's protocol ID
- QLS32015-301
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07138209
- Acronym / sponsor ID
- QLS32015-301
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS32015 | Experimental | Drug: QLS32015Participants will receive teclistamab monotherapy. |
| Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd) | Experimental | Drug: Pomalidomide, Drug: Selinexor, Drug: DexamethasoneParticipants will receive either Pd or Sd based on principal investigator's choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS32015QLS32015 will be administered subcutaneously. | Drug | QLS32015 |
| PomalidomidePomalidomide will be administered orally. | Drug | Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd) |
| SelinexorSelinexor will be administered orally. | Drug | Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd) |
| DexamethasoneDexamethasone will be administered orally | Drug | Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd) |
Primary outcome
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.
7 secondary outcomes
Overall Response (Partial Response [PR] or Better)
Time frame: Up to 4 years
Very Good Partial Response (VGPR) or Better Response
Time frame: Up to 4 years
Complete Response (CR) or Better Response
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 4 years
Minimal Residual Disease (MRD) Negativity
Time frame: Up to approximately 4 years
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 4 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLS32015, Pomalidomide and Selinexor in people with Relapsed or Refractory Multiple Myeloma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An, Professor (008613502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.