Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07585760

CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-14

20

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by severe renal impairment (\[eGFR\] \< 30 mL/min). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.

CONDITIONS

Official Title

CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Newly diagnosed symptomatic multiple myeloma according to IMWG criteria
  • Measurable disease with serum M-protein ≥ 1 g/dL, or urine M-protein ≥ 200 mg/24 hours, or abnormal serum free light chain ratio with involved serum FLC ≥ 100 mg/L
  • Severe myeloma-related renal impairment with eGFR < 30 mL/min due to cast nephropathy confirmed by biopsy or clinical judgment
  • ECOG performance status score ≤ 2
  • Adequate hematological function: ANC ≥ 1.0 × 10^9/L without recent growth factor use, hemoglobin ≥ 60 g/L without recent transfusions, platelet count ≥ 50 × 10^9/L without recent transfusions or thrombopoietin receptor agonists
  • Adequate hepatic function: ALT and AST ≤ 3 × ULN, total bilirubin ≤ 2 × ULN (with exceptions for Gilbert's syndrome)
  • Coagulation function: INR or APTT ≤ 1.5 × ULN
  • No active other malignancies or malignancies with expected survival < 12 months
  • Willingness to participate, good compliance, and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of smoldering multiple myeloma, MGUS, Waldenström's macroglobulinemia, POEMS syndrome, amyloidosis, or secondary plasma cell leukemia
  • Central nervous system involvement or meningeal disease
  • Severe or uncontrolled cardiac diseases such as unstable angina, recent myocardial infarction (within 6 months), severe arrhythmias, or other cardiovascular conditions deemed unsuitable
  • Active infections including HIV, active hepatitis B or C, active or latent syphilis, active tuberculosis, or other infections unsuitable for participation
  • Concurrent malignancies or severe diseases compromising safety or study completion
  • Pregnant or breastfeeding women
  • History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to study drugs
  • Unable or unwilling to sign informed consent
  • Any other conditions considered unsuitable for enrollment by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China, 300000

Actively Recruiting

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Research Team

G

Gang An, PhD & MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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