CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment (NCT07585760) | Clinical Trial Compass
RecruitingPhase 2
CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Severe Renal Impairment
China20 participantsStarted 2026-05-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 80 years.
. Newly diagnosed symptomatic multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) criteria. Patients who have received up to 1 cycle of prior anti-myeloma therapy, excluding immunotherapeutic agents, are allowed to enroll.
. Presence of measurable disease at diagnosis, meeting at least one of the following criteria:
. Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula). The type of renal impairment must be restricted to cast nephropathy, which can be confirmed by renal biopsy or by the investigator's clinical judgment based on light chain proteinuria. If urine albumin accounts for more than 30% of the total urine protein, a renal biopsy is mandatory to confirm cast nephropathy.
. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Renal Response Rate (Minor Response or better)
Timeframe: At the end of Cycle 3 (each cycle is 28 days)
Trial details
NCT IDNCT07585760
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Adequate major organ function, meeting the following criteria:
. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L, and without receiving granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, or pegylated G-CSF within 14 days prior to testing;
. Hemoglobin ≥ 60 g/L, and without receiving whole blood or red blood cell transfusions within 7 days prior to testing;
Exclusion criteria
. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis, or secondary plasma cell leukemia.
. Central nervous system (CNS) involvement or clinical evidence of meningeal involvement.
. Severe and/or uncontrolled cardiac diseases, including: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe and uncontrolled arrhythmias; or other cardiovascular/cerebrovascular diseases deemed unsuitable for study participation by the investigator.
. Presence of active infections, including: HIV positive; active Hepatitis B (HBV-DNA positive); active Hepatitis C (HCV-RNA positive); active or latent syphilis infection (Treponema pallidum antibody positive); active tuberculosis (active TB infection indicated by chest imaging or other relevant tests within the past 3 months or during the screening period); or other active infections deemed unsuitable for study participation by the investigator.
. Patients with concurrent malignancies; or severe concomitant diseases that, in the investigator's judgment, would severely compromise patient safety or interfere with study completion.
. Pregnant or lactating women.
. History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to any components of the study drugs.
. Unable or unwilling to sign the informed consent form.