Relapsed or Refractory Multiple Myeloma (RRMM)Phase 3NCT07579234
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
A Phase 3 study testing F182112 single-agent and Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd) in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- F182112 single-agent and Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2026to 25 Jan 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria 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 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:
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- 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;
- 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 parameters specifically permitted in the inclusion criteria;
- Have an expected survival of ≥3 months.
Who cannot join
- 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);
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- 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;
- 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 permitted;
- 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 study procedures;
- 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 accepted effective contraceptive method (e.g., intrauterine device or condom) during the study period;
- 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 unwillingness to receive prophylactic antithrombotic therapy as required by protocol), or life-threatening allergic reaction or intolerance to pomalidomide;
- Previously received selinexor or have a contraindication to selinexor or life-threatening allergic reaction or intolerance to selinexor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjing
Lu gui Qiu Doctor, (+86)13821266636, Qiulg@ihcams.ac.cn
About this study
Official title: Phase III Clinical Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma
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
Read the detailed description
This is a multicenter, randomized, open-label, parallel-group, controlled, superiority Phase III clinical study designed to compare the efficacy and safety of F182112 with standard of care in patients with relapsed or refractory multiple myeloma (RRMM). The study population consists of RRMM patients 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. The primary endpoint is PFS, with progression defined by IRC according to the 2016 IMWG criteria.
- Being tested
- F182112 single-agent, Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F182112 single-agentDrug
F182112 single-agent
Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)Drug
Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd)
| Study group | Role | What they receive |
|---|---|---|
| F182112 single-agent | Experimental | F182112 single-agent Receives: Drug: F182112 single-agent |
| PVd or SVd | Active comparator | Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd) Receives: Drug: Pomalidomide + Bortezomib + Dexamethasone (PVd) or Selinexor + Bortezomib + Dexamethasone (SVd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the progression-free survival (PFS) evaluated by the Independent Review Committee (IRC) according to the 2016 IMWG criteria
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start25 Jan 2026
- Primary completion25 Jan 2029 (estimated)
- Study completion25 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579234
- Sponsor's protocol ID
- NTP-F182112-201
- Status last verified
- Jan 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No