Not yet taking people in ChinaPhase 3
CM336 and CM313 Compared With Standard Treatment for Relapsed or Refractory Multiple Myeloma
Compares CM336 plus CM313 with standard drugs in adults whose multiple myeloma returned.
Key facts
- Who runs it
- Keymed Biosciences Co.Ltd
- Where
- Tianjin, ChinaSee the site
- Trial code
- Registry title
- Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 320 people, planned
- Starts
- Dec 2026
- Expected to end
- Nov 2030
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CM336
- CM313
- Daratumumab
- Pomalidomide
- Dexamethasone
- Record updated
- 2 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose multiple myeloma came back or did not respond after 1 to 3 earlier lines of treatment. It compares CM336 + CM313 with daratumumab + pomalidomide + dexamethasone.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory multiple myeloma. The disease got worse or did not respond after the last treatment. It must be measurable at screening. ECOG performance status score of 0 to 2.
- Earlier treatment
- Must have had 1 to 3 earlier lines of treatment, including at least one proteasome inhibitor and one immunomodulatory drug. Must not have had any BCMA-targeted therapy.
- Biomarker or test result
- Measurable disease: serum M-protein ≥5 g/L, or urine M-protein ≥200 mg/24 h, or involved serum FLC ≥100 mg/L with an abnormal κ/λ ratio.
Main reasons for not taking part
- Any earlier BCMA-targeted therapy
- Disease refractory to anti-CD38 therapy
- Contraindication, severe allergy or intolerance to pomalidomide
- Primary light-chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or solitary plasmacytoma
- Corticosteroids equal to ≥140 mg prednisone within 14 days, or a live vaccine within 4 weeks, before randomization
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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:; 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 take part
- Received any prior B cell maturation antigen (BCMA)-targeted therapy
- 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
- 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
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaContact: Lugui QiuNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Part 1:CM336+CM313Treatment being tested
Treatment: CM336 and CM313
- Part 2,Arm A: CM336+CM313Treatment being tested
Treatment: CM336 and CM313
- Part 2,Arm B: Daratumumab + Pomalidomide +DexamethasoneExisting treatment, for comparison
Treatment: Daratumumab, Pomalidomide, and Dexamethasone
- Part 2,Arm C: CM336Treatment being tested
Treatment: CM336
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- CM336 and CM313 Compared With Standard Treatment for Relapsed or Refractory Multiple MyelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 November 2026