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Compares treatment options for Relapsed or Refractory Multiple Myeloma (RRMM)
Official title A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing the Efficacy and Safety of F182112 Versus Standard of Care in Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07579234
What this study is testing
What is F182112 single-agent?
F182112 single-agent is an investigational medicine, being studied as a potential treatment for relapsed or refractory multiple myeloma (rrmm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Multicenter, Randomized, Open-label, Parallel-group, Controlled, Superiority Phase III Clinical Study Comparing F182112 with Standard of Care in Patients with Relapsed or Refractory Multiple Myeloma
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all of the following to be eligible for enrollment in this study:
- Provide informed consent and voluntarily sign the informed consent form; Be male or female, aged ≥18 years;
- Have relapsed or refractory multiple myeloma (RRMM) who have previously failed therapy with regimens containing at least one agent from each of the...
- Before randomization, the investigator must pre-select a standard of care (SOC) treatment regimen based on the patient's disease status;
- Have an ECOG performance status of 0-2;
You likely can't join if
- Central nervous system involvement or clinical symptoms of meningeal involvement by multiple myeloma;
- Concomitant light chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, or POEMS syndrome;
- History of any other malignancy within 3 years prior to first dose, except for malignancies with very low recurrence risk after curative treatment...
- Dysphagia or active gastrointestinal dysfunction that may impair drug absorption;
- Evidence of cardiovascular risk, including any of the following:
- QTc interval: ≥450 ms in males, ≥470 ms in females (QT interval must be corrected for heart rate using Friderici's formula);
See the full eligibility criteria
Who can join
- Patients must meet all of the following to be eligible for enrollment in this study:
- Provide informed consent and voluntarily sign the informed consent form; Be male or female, aged ≥18 years;
- Have relapsed or refractory multiple myeloma (RRMM) who have previously failed therapy with regimens containing at least one agent from each of the following three drug classes: proteasome inhibitors, immunomodulatory...
- Before randomization, the investigator must pre-select a standard of care (SOC) treatment regimen based on the patient's disease status;
- Have an ECOG performance status of 0-2;
- Have at least one measurable disease parameter:
- Serum M-protein ≥5 g/L;
- Urine M-protein ≥200 mg/24 h;
- Serum free light chain (FLC) assay: involved FLC level ≥100 mg/L with an abnormal serum FLC ratio (\ 1.65);
- Have organ function meeting the following requirements (no blood components or hematopoietic growth factors permitted within 7 days prior to first dose):
- Hematology: Absolute neutrophil count (ANC) ≥1.0×10⁹/L, hemoglobin ≥70 g/L, platelets ≥50×10⁹/L;
- Liver function: Total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN;
- Renal function: Creatinine clearance ≥30 mL/min;
- All prior treatment-related toxicities (as defined by NCI CTCAE v6.0) must be ≤Grade 1 at screening, except for alopecia, non-clinically significant and asymptomatic Grade 2 laboratory abnormalities, and those...
- Have an expected survival of ≥3 months.
What rules you out
- Central nervous system involvement or clinical symptoms of meningeal involvement by multiple myeloma;
- Concomitant light chain amyloidosis, plasma cell leukemia, Waldenström macroglobulinemia, or POEMS syndrome;
- History of any other malignancy within 3 years prior to first dose, except for malignancies with very low recurrence risk after curative treatment (e.g., squamous cell carcinoma or basal cell carcinoma of the skin, in...
- Dysphagia or active gastrointestinal dysfunction that may impair drug absorption;
- Evidence of cardiovascular risk, including any of the following:
- QTc interval: ≥450 ms in males, ≥470 ms in females (QT interval must be corrected for heart rate using Friderici's formula);
- Left ventricular ejection fraction (LVEF) \<50%;
- Electrocardiographic abnormalities deemed by the investigator to pose unacceptable risk, including clinically significant untreated or uncontrolled arrhythmias, second-degree (Mobitz II) or third-degree atrioventricular...
- History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stent placement, or bypass surgery within 6 months prior to screening;
- Heart failure classified as NYHA Class III or IV;
- Uncontrolled severe hypertension (systolic blood pressure ≥170 mmHg or diastolic blood pressure ≥110 mmHg);
- Active infection requiring antimicrobial, antiviral, or antifungal therapy (prophylactic therapy excluded):
- Oral antimicrobial therapy within 2 weeks prior to first dose;
- Intravenous antimicrobial therapy within 4 weeks prior to first dose;
- History of viral respiratory infection (e.g., COVID-19, influenza A or B) within 2 weeks prior to first dose;
- Serological findings:
- HBsAg positive and/or HbcAb positive with HBV-DNA positive or above upper limit of normal (ULN); HCV antibody positive with HCV-RNA positive or above ULN;
- Active autoimmune disease, including HIV infection. Patients with well-controlled type 1 diabetes, euthyroid autoimmune thyroiditis, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) are...
- Active syphilis infection;
- Active tuberculosis (evidenced by chest imaging or other relevant testing within 3 months prior to screening or during screening; tuberculosis screening will be conducted per center protocol);
- Received live or attenuated vaccine within 4 weeks prior to first dose;
- Underwent major surgery within 4 weeks prior to first dose, or anticipated to undergo major surgery during the study period;
- Received the following anti-myeloma therapies prior to first dose:
- Plasmapheresis within 28 days prior to first dose;
- Monoclonal antibody therapy within 21 days prior to first dose;
- Small molecule targeted therapy, cytotoxic chemotherapy, and/or proteasome inhibitor and/or other anti-tumor traditional Chinese medicine within 14 days or 5 half-lives (whichever is shorter) prior to first dose;
- Systemic corticosteroids (prednisone \>10 mg/day or equivalent dose) within 7 days prior to first dose;
- Autologous stem cell transplantation within 3 months prior to first dose;
- CAR-T or CAR-NK cell therapy within 3 months prior to first dose;
- Previously received allogeneic stem cell transplantation;
- Previously received BCMA-targeted therapy;
- Plan to receive other anticancer therapy or investigational drugs during the study period;
- Any severe and/or unstable pre-existing medical condition, psychiatric disorder, or other disease (including laboratory abnormalities) that may affect participant safety, informed consent acquisition, or adherence to...
- Pregnant or lactating women; male participants (or their partners) or female participants who plan to become pregnant during the study or within 6 months after the last dose, and who are unwilling to use a medically...
- Any patient deemed unsuitable for participation by the investigator.. SAT-specific exclusion criteria:
- Inability to receive bortezomib as determined by the investigator;
- Contraindication to bortezomib or history of life-threatening allergic reaction or intolerance (defined as drug-related AE leading to discontinuation of treatment);
- Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy;
- Received a strong CYP3A4 inducer within 5 half-lives prior to first dose;
- Previously received pomalidomide or have a contraindication to pomalidomide (e.g., history of arterial or deep vein thrombosis within the past 3 months [except intermuscular vein thrombosis], contraindication to or...
- Previously received selinexor or have a contraindication to selinexor or life-threatening allergic reaction or intolerance to selinexor.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.