F182112 in Combination With Isatuximab and Lenalidomide for the Treatment of Patients With Newly Diagnosed Multiple Myeloma (CAREMM-009)
Safety and Efficacy of F182112 in Combination With Isatuximab and Lenalidomide in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma: A Prospective, Single-Arm, Exploratory Clinical Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Gang An
- Phone Number: 86-022-23909171
- Email: angang@ihcams.ac.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Trial participants must voluntarily sign the informed consent form (ICF).
- Aged 18-70 years.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2.
- Diagnosed with newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease. At least one of the following criteria must be met:
1. Serum M-protein level ≥1.0 g/dL; 2. Urine M-protein level ≥200 mg/24 hours; 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio.
5. Previously received no more than one course of systemic therapy. 6. Liver function tests must meet the following criteria: total bilirubin <1.5 × upper limit of normal (ULN) (total bilirubin <3 × ULN for patients with Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × ULN.
7. Renal function must meet the following criterion: creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
8. Complete blood count within 14 days prior to the start of screening must meet the following criteria: white blood cell (WBC) count ≥1.0 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, hemoglobin ≥70 g/L, and platelet count ≥50 × 10⁹/L; or the investigator determines that the participant is suitable for enrollment based on the actual clinical situation.
9. For patients receiving hematopoietic growth factor support, including erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists, etc. (e.g., eltrombopag, TPO, interleukin-11), there must be an interval of 2 weeks between receiving growth factor support and screening assessment.
10. The patient is able to receive the prophylactic anticoagulation therapy recommended by the study.
11. Women of non-childbearing potential are eligible for enrollment; female patients of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) or urine pregnancy test at screening.
12. Male patients, women of childbearing potential, and their partners must voluntarily use effective contraceptive measures, as deemed appropriate by the investigator, during treatment and for at least 3 months after treatment.
13. Male patients must agree not to donate sperm from the initial screening period until 90 days after the last dose.
**Note:** Women of childbearing potential are defined as all women who have experienced menarche and are not postmenopausal and have not undergone surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). Postmenopausal status is defined as amenorrhea for more than 12 consecutive months without another specified cause. Women using mechanical contraceptive methods such as oral contraceptives or intrauterine devices should be considered to have childbearing potential. Male trial participants, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plan to impregnate a female partner from the date of signing the informed consent form, throughout the use of the investigational drug, and for 3 months after the last administration of the investigational drug.
Exclusion Criteria:
- Diagnosed with smoldering multiple myeloma, POEMS syndrome, amyloidosis, or plasma cell leukemia.
- Presence of central nervous system involvement.
- Patients with severe and/or uncontrolled cardiac disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, or severe and uncontrolled arrhythmia; or other cardiovascular or cerebrovascular diseases that, in the investigator's judgment, make the patient unsuitable for participation in this study.
- Presence of active infection, including HIV positivity; active hepatitis B infection (HBV-DNA positive); active hepatitis C infection (HCV-RNA positive); active or latent syphilis infection (positive Treponema pallidum antibody); active pulmonary tuberculosis, as indicated by chest imaging or other relevant examinations within the past 3 months or during the screening period; or other infections that, in the investigator's judgment, make the patient unsuitable for participation in this study.
- Patients with concurrent other malignancies; or patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or affect the patient's ability to complete the study.
- Contraindication to, or life-threatening allergy, hypersensitivity, or intolerance to, any study drug or excipient.
- Pregnant or breastfeeding women.
- Life expectancy <6 months.
Trial participants who have undergone major surgery, such as surgery requiring general anesthesia, within 2 weeks prior to enrollment; who will not have fully recovered from surgery; or who are scheduled to undergo surgery during the planned study period. Kyphoplasty or vertebroplasty is not considered major surgery.
- Note:** Trial participants scheduled to undergo surgical procedures under local anesthesia may participate in the study.
- Any active severe psychiatric disorder, medical disease, or other symptom/condition that, in the investigator's judgment, may affect treatment, compliance, or the ability to provide informed consent.
- Unable or unwilling to sign the informed consent form.
- Other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BsAbs-treatment group
All enrolled patients will first receive induction therapy based on F182112 + Isa-R for a total of six cycles.
After completing induction therapy, study participants will enter the F182112 + Isa maintenance phase, which will continue for up to 18 cycles.
During maintenance therapy, MRD assessment will be performed dynamically every 3 to 6 months.
|
Induction treatment phase: F182112: Administered by intravenous infusion.
Patients will receive three step-up doses of F182112 at 3 μg/kg, 30 μg/kg, and 180 μg/kg on Days 1, 4, and 8 of Cycle 1, respectively, followed by intravenous administration of F182112 at 180 μg/kg once weekly.
Isatuximab: Administered by intravenous infusion at 10 mg/kg.
Patients will receive isatuximab on Days 1, 8, 15, and 22 of Cycle 1, and on Days 1 and 15 of each cycle from Cycle 2 to Cycle 6. Lenalidomide: Administered orally at 25 mg on Days 1-21 of each cycle.
Maintenance treatment phase: F182112: Administered by intravenous infusion at 180 μg/kg once every 2 weeks.
If sustained MRD negativity is maintained for more than 6 months after completion of induction treatment, the investigator may consider adjusting the subsequent dosing frequency to once every 4 weeks.
Isatuximab: Administered by intravenous infusion at 10 mg/kg.
During the maintenance treatment phase, isatuximab will be administered once
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The incidence and outcomes of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) occurring from the initiation of the first study treatment through the end of Cycle 6, or through 30 days after premature discontinuation of study t
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MRD negativity rate after 6 cycles (10-6)
Time Frame: 6 months
|
6 months
|
|
MRD negativity rate after 6 cycles (10-5)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Multiple Myeloma
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Carboxylic Acids
- Piperidines
- Phthalimides
- Phthalic Acids
- Acids, Carbocyclic
- Piperidones
- Isoindoles
- Lenalidomide
- isatuximab
Other Study ID Numbers
- IIT2026102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.