Relapsed or Refractory Multiple MyelomaPhase 2NCT07018050
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
A Phase 2 study testing QLS32015, Pomalidomide and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide. 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 Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to Jul 2028
- Phase
- Phase 2
- 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
- Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;
- Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;
- Measurable disease at screening, defined by at least one of the following:
- Serum M-protein ≥1.0 g/dL (10 g/L);
- Urine M-protein ≥200 mg/24 hours;
- Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.
Who cannot join
- History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);
- Prior anti-myeloma therapies within the specified timeframes before enrollment:
- Previous treatment with GPRC5D-targeted therapy;
- Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T], natural killer [NK] cell therapy) within 3 months;
- Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);
- Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);
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- Cytotoxic therapy or monoclonal antibodies within 21 days;
- Proteasome inhibitor therapy within 14 days;
- Immunomodulatory drug therapy within 7 days;
- Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]);
- Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
- Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);
- Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);
- Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).
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
Institute of Hematology & Blood Diseases Hospital
Tianjin
Gang An, 008613502181109, angang@ihcams.ac.cn
About this study
Official title: A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- QLS32015, Pomalidomide, Dexamethasone, QL2109 or Daratumumab, Bortezomib
- 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 self-administered as a single dose orally
DexamethasoneDrug
Dexamethasone will be administered orally or intravenously
QL2109 or DaratumumabDrug
QL2109 or Daratumumab will be administered subcutaneously.
BortezomibDrug
Bortezomib will be administered subcutaneously
LenalidomideDrug
Lenalidomide will be self-administered as a single dose orally
| Study group | Role | What they receive |
|---|---|---|
| QLS32015(SC) in combination with Pomalidomide | Experimental | Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Receives: Drug: QLS32015; Drug: Pomalidomide; Drug: Dexamethasone |
| QLS32015(SC) in combination with QL2109 or Daratumumab. | Experimental | Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Receives: Drug: QLS32015; Drug: Dexamethasone; Drug: QL2109 or Daratumumab |
| QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide | Experimental | Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug Receives: Drug: QLS32015; Drug: Pomalidomide; Drug: Dexamethasone; Drug: QL2109 or Daratumumab |
| QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide | Experimental | Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug Receives: Drug: QLS32015; Drug: Dexamethasone; Drug: Bortezomib; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Partial Response [PR] or Better)
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria
Measured: Up to 2 years
Overall Minimal Residual Disease (MRD)
MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy
Measured: Up to 2 years
Secondary outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start12 Sep 2025
- Primary completionNov 2027 (estimated)
- Study completionJul 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT07018050
- Sponsor's protocol ID
- QLS32015-202
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2025
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07018050
- Acronym / sponsor ID
- QLS32015-202
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Jun 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 the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLS32015(SC) in combination with Pomalidomide | Experimental | Drug: QLS32015, Drug: Pomalidomide, Drug: DexamethasoneParticipants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
| QLS32015(SC) in combination with QL2109 or Daratumumab. | Experimental | Drug: QLS32015, Drug: Dexamethasone, Drug: QL2109 or DaratumumabParticipants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
| QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide | Experimental | Drug: QLS32015, Drug: Pomalidomide, Drug: Dexamethasone, Drug: QL2109 or DaratumumabParticipants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug |
| QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide | Experimental | Drug: QLS32015, Drug: Dexamethasone, Drug: Bortezomib, Drug: LenalidomideParticipants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;
- Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;
- Measurable disease at screening, defined by at least one of the following:
Key exclusion criteria (14 listed)
- History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);
- Prior anti-myeloma therapies within the specified timeframes before enrollment:
- Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]);
- Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
- Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);
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(SC) in combination with Bortezomib for injection and Lenalidomide, QLS32015(SC) in combination with Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab. |
| PomalidomidePomalidomide will be self-administered as a single dose orally | Drug | QLS32015(SC) in combination with Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide |
| DexamethasoneDexamethasone will be administered orally or intravenously | Drug | QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide, QLS32015(SC) in combination with Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab. |
| QL2109 or DaratumumabQL2109 or Daratumumab will be administered subcutaneously. | Drug | QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide, QLS32015(SC) in combination with QL2109 or Daratumumab. |
| BortezomibBortezomib will be administered subcutaneously | Drug | QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide |
| LenalidomideLenalidomide will be self-administered as a single dose orally | Drug | QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide |
Primary outcome
ORR (Partial Response [PR] or Better)
Time frame: Up to 2 years
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria
Overall Minimal Residual Disease (MRD)
Time frame: Up to 2 years
MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: Up to 2 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 8 Jun 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 2 study testing QLS32015, Pomalidomide and Dexamethasone 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 6 inclusion and 14 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 8 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
ORR (Partial Response [PR] or Better) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 8 Jun 2026.