Multiple Myeloma (MM)Phase 3NCT07910903
Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 3 study testing CM336, CM313 and Daratumumab in people with Multiple Myeloma (MM), run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This study consists of two parts. The purpose of Part 1 is to evaluate the safety and tolerability of CM336+CM313 combination therapy in participants with relapsed or refractory multiple myeloma (RRMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- CM336, CM313 and Daratumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Dec 2026to Nov 2030
- 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
- Signed informed consent form.
- Age ≥18 years. Gender is not limited.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug.
- Investigator-assessed evidence of disease progression or failure to achieve response after the last line of therapy, according to the International Myeloma Working Group (2016IMWG) criteria.
- Measurable disease at screening, defined by at least one of the following:
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- Serum M-protein≥5 g/L;
- Urine M-protein≥200 mg/24 h;
- Involved serum FLC level≥100 mg/L with an abnormal κ/λ ratio.
Who cannot join
- Received any prior B cell maturation antigen (BCMA)-targeted therapy.
- IMWG-defined disease refractory to anti-CD38 therapy.
- Participants are not eligible to receive DPd as control therapy if any of the following are present: Contraindication, life-threatening hypersensitivity, or intolerance to pomalidomide.
- Participants with primary light-chain amyloidosis (AL), plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or solitary plasmacytoma.
- Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before randomization.
- Received a live, attenuated vaccine within 4 weeks before randomization.
- Contraindication, intolerance, or life-threatening allergy to any investigational product or excipient.
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
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Lugui Qiu, 028-88610620, clinicaltrial@keymedbio.com
Gang An, 028-88610620, clinicaltrial@keymedbio.com
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study To Compare the Efficacy and Safety of CM336 + CM313 Combination Therapy Versus Daratumumab + Pomalidomide +Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy
This study consists of two parts. The purpose of Part 1 is to evaluate the safety and tolerability of CM336+CM313 combination therapy in participants with relapsed or refractory multiple myeloma (RRMM). Part 2 is to compare the efficacy of CM336 + CM313 (Group A) with Daratumumab + Pomalidomide +Dexamethasone (DPd) (Group B) in RRMM patients.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- CM336, CM313, Daratumumab, Pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336Drug
Specified dose on specified days
CM313Drug
Specified dose on specified days
DaratumumabDrug
Specified dose on specified days
PomalidomideDrug
Specified dose on specified days
DexamethasoneDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1:CM336+CM313 | Experimental | Not described Receives: Drug: CM336; Drug: CM313 |
| Part 2,Arm A: CM336+CM313 | Experimental | Not described Receives: Drug: CM336; Drug: CM313 |
| Part 2,Arm B: Daratumumab + Pomalidomide +Dexamethasone | Active comparator | Not described Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone |
| Part 2,Arm C: CM336 | Experimental | Not described Receives: Drug: CM336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Frequency of Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a study participant receiving study product, whether or not related to the product. Severity graded per CTCAE version 6.0.
Measured: Up to 4 years
Part 2: 9-Month Minimal Residual Disease (MRD) Negative Complete Response (CR)
MRD negative CR at Month 9 (±3 months) is defined as participants who have MRD negative status at Month 9±3 months (prior to progression or subsequent antimyeloma therapy) and have achieved CR or better per IMWG criteria at any time post-randomization up to Month 9±3 months.
Measured: At month 9
Part 2: Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to disease progression or death, whichever occurs first. Disease progression will be assessed according to IMWG criteria.
Measured: 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 posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910903
- Sponsor's protocol ID
- CM336-021210
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Phase 3 Study To Compare the Efficacy and Safety of CM336 + CM313 Combination Therapy Versus Daratumumab + Pomalidomide +Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy
- ClinicalTrials.gov ID
- NCT07910903
- Acronym / sponsor ID
- CM336-021210
- Conditions
- Multiple Myeloma (MM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 2 Nov 2026 (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.
This study consists of two parts. The purpose of Part 1 is to evaluate the safety and tolerability of CM336+CM313 combination therapy in participants with relapsed or refractory multiple myeloma (RRMM). Part 2 is to compare the efficacy of CM336 + CM313 (Group A) with Daratumumab + Pomalidomide +Dexamethasone (DPd) (Group B) in RRMM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1:CM336+CM313 | Experimental | Drug: CM336, Drug: CM313 |
| Part 2,Arm A: CM336+CM313 | Experimental | Drug: CM336, Drug: CM313 |
| Part 2,Arm B: Daratumumab + Pomalidomide +Dexamethasone | Active comparator | Drug: Daratumumab, Drug: Pomalidomide, Drug: Dexamethasone |
| Part 2,Arm C: CM336 | Experimental | Drug: CM336 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent form.
- Age ≥18 years. Gender is not limited.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- Participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug.
- Investigator-assessed evidence of disease progression or failure to achieve response after the last line of therapy, according to the International Myeloma Working Group (2016IMWG) criteria.
Key exclusion criteria (7 listed)
- Received any prior B cell maturation antigen (BCMA)-targeted therapy.
- IMWG-defined disease refractory to anti-CD38 therapy.
- Participants are not eligible to receive DPd as control therapy if any of the following are present: Contraindication, life-threatening hypersensitivity, or intolerance to pomalidomide.
- Participants with primary light-chain amyloidosis (AL), plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or solitary plasmacytoma.
- Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before randomization.
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 |
|---|---|---|
| CM336Specified dose on specified days | Drug | Part 1:CM336+CM313, Part 2,Arm A: CM336+CM313, Part 2,Arm C: CM336 |
| CM313Specified dose on specified days | Drug | Part 1:CM336+CM313, Part 2,Arm A: CM336+CM313 |
| DaratumumabSpecified dose on specified days | Drug | Part 2,Arm B: Daratumumab + Pomalidomide +Dexamethasone |
| PomalidomideSpecified dose on specified days | Drug | Part 2,Arm B: Daratumumab + Pomalidomide +Dexamethasone |
| DexamethasoneSpecified dose on specified days | Drug | Part 2,Arm B: Daratumumab + Pomalidomide +Dexamethasone |
Primary outcome
Part 1: Frequency of Adverse Events (AEs)
Time frame: Up to 4 years
An adverse event is any untoward medical occurrence in a study participant receiving study product, whether or not related to the product. Severity graded per CTCAE version 6.0.
Part 2: 9-Month Minimal Residual Disease (MRD) Negative Complete Response (CR)
Time frame: At month 9
MRD negative CR at Month 9 (±3 months) is defined as participants who have MRD negative status at Month 9±3 months (prior to progression or subsequent antimyeloma therapy) and have achieved CR or better per IMWG criteria at any time post-randomization up to Month 9±3 months.
Part 2: Progression Free Survival (PFS)
Time frame: Up to 4 years
PFS is defined as the duration from the date of randomization to disease progression or death, whichever occurs first. Disease progression will be assessed according to IMWG criteria.
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 2 Nov 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 CM336, CM313 and Daratumumab in people with Multiple Myeloma (MM), run by Keymed Biosciences 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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Nov 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 Qian Jia (028-88610620, clinicaltrial@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Frequency of Adverse Events (AEs) (time frame: Up to 4 years). The study lists 3 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 2 Nov 2026.