Clinical Trials in China / NCT07910903
Starting soon
Phase 3
Study of CM336+CM313 Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
NCT07910903 · tracked via the Priya Life Science China tracker
Condition(s) studied
Multiple Myeloma (MM)
Investigational drug(s) / intervention(s)
CM336: Specified dose on specified days
CM313: Specified dose on specified days
Daratumumab: Specified dose on specified days
Pomalidomide: Specified dose on specified days
Dexamethasone: Specified dose on specified days
Study 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). Part 2 is to compare the efficacy of CM336 + CM313 (Group A) with Daratumumab + Pomalidomide +Dexamethasone (DPd) (Group B) in RRMM patients.
Eligibility
Inclusion Criteria:
* 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:
1. Serum M-protein≥5 g/L;
2. Urine M-protein≥200 mg/24 h;
3. Involved serum FLC level≥100 mg/L with an abnormal κ/λ ratio.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Part 1: Frequency of Adverse Events (AEs) — 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) — 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) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07910903 on ClinicalTrials.gov ↗ ← All trials in China