CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Renal Impairment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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 renal impairment (\[eGFR\] \< 40 mL/min). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 are allowed to enroll.
Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) < 40 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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CM336 Plus Isatuximab
DrugCM336: Administered subcutaneously (SC) via a step-up dosing regimen, which includes a step-up dosing phase and a target dosing phase. Upon reaching the target dose, it will be administered once weekly. Isatuximab: Administered intravenously (IV) at a dose of 10 mg/kg, given weekly during Cycle 1, and every two weeks during Cycles 2 and 3.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: CM336 plus IsatuximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Renal Response Rate (Minor Response or better)
The Overall Renal Response Rate is defined as the percentage of participants who achieve a renal response of Minor Response or better (including Minor Response, Partial Response, and Complete Response) according to the International Myeloma Working Group (IMWG) criteria for renal impairment.
Time frame
At the end of Cycle 3 (each cycle is 28 days)Secondary outcomes
1
Rate of Renal Partial Response or Better
Rate of renal partial response or better is defined as the percentage of participants who achieve a renal response of Partial Response or better (including Partial Response and Complete Response) according to the International Myeloma Working Group (IMWG) criteria for renal impairment.
Time frame
At the end of Cycle 3 (each cycle is 28 days)2
Hematological Overall Response Rate (ORR)
The percentage of participants who achieve a hematological response of Partial Response (PR) or better (including PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and Stringent Complete Response \[sCR\]) according to the International Myeloma Working Group (IMWG) uniform response criteria.
Time frame
From the first dose of CM336 through 30 days after the last dose of CM3363
MRD Negativity Rate
The percentage of participants who achieve MRD negativity in the bone marrow. MRD negativity is defined by a threshold of 10\^-5, assessed via Next-Generation Flow (NGF) cytometry in accordance with IMWG criteria.
Time frame
At the end of Cycle 3 (each cycle is 28 days)4
Kinetics of Serum Free Light Chain (sFLC) Reduction
The rate and time to achieve a specific percentage or absolute reduction in involved serum free light chain (sFLC) levels from baseline.
Time frame
From the first dose of CM336 through 30 days after the last dose of CM336Sponsors and contacts
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Source ClinicalTrials.gov