NCT07910903Not yet recruitingPhase 3
Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- Dec 2026
- Primary completion date
- May 2030
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Multiple myeloma
- NCT number
- NCT07910903
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 320
- From Dec 2026 to the primary completion date, May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.