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

NCT07579234 | Recruiting Phase 3

• 1 other identifier: NTP-F182112-201
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Outcome Measures

Primary Outcomes (1)

• the progression-free survival (PFS) evaluated by the Independent Review Committee (IRC) according to the 2016 IMWG criteria

  2 year

Study Arms (2)

F182112 single-agent

EXPERIMENTAL

F182112 single-agent

Drug: F182112 single-agent

PVd or SVd

ACTIVE COMPARATOR

Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)

Drug: Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)

Interventions

F182112 single-agent DRUG

F182112 single-agent

F182112 single-agent

Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd) DRUG

Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)

PVd or SVd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 agents, and anti-CD38 monoclonal antibodies; i. Relapsed: Disease progression requiring salvage therapy after achieving a minimal response (MR) or better following prior anti-myeloma therapy; ii. Refractory: Lack of response (failure to achieve MR or better) during the last anti-myeloma therapy, or disease progression within 60 days after the last anti-myeloma therapy;
• 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 (\<0.26 or \>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;
• Have an expected survival of ≥3 months.

You may not qualify 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 (e.g., squamous cell carcinoma or basal cell carcinoma of the skin, in situ cervical or breast cancer), or those who have undergone curative surgical resection (or other treatment) with no current evidence of disease and unlikely to impact survival during the study period;
• 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 (AV) block;
• 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;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjing, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

pomalidomide; Bortezomib; Dexamethasone; selinexor

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Lu gui Qiu Doctor

CONTACT

（+86）13821266636; Qiulg@ihcams.ac.cn

Shaohong Yin, Ext.

CONTACT

15764210553; yinshaohong@vip.lunan.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): January 25, 2029
• Study Completion (Estimated): January 25, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)