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.
Plain-language title generated from the registry record
Registry title: Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 3
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaNo longer taking part
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?
Trial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT07910903
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.