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New treatment option for Multiple Myeloma
Official title SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease
ClinicalTrials.gov ID: NCT05900882
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as S.
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
- The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men and women aged with18-75 years old.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- Newly diagnosed patients presenting with extramedullary disease (EMD) including solely paraskeletal plasmacytoma, plasmacytoma of soft tissue and...
- ANC≥1.0\ 10\^9/L, HGB≥75\ 10\^9/L, PLT≥50\ 10\^9/L (≥50% of bone marrow nucleated cells are plasma cells).
- Patients whose expecting survival time will be more than 3 months.
You likely can't join if
- Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases.
- Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0.
- Plasma cell leukemia.
- Serious thrombotic events.
- Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b. Uncontrolled, clinically significant conduction abnormalities (except...
- Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)).
See the full eligibility criteria
- Men and women aged with18-75 years old.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- Newly diagnosed patients presenting with extramedullary disease (EMD) including solely paraskeletal plasmacytoma, plasmacytoma of soft tissue and other special sites detected by physical exam and confirmed by...
- ANC≥1.0\ 10\^9/L, HGB≥75\ 10\^9/L, PLT≥50\ 10\^9/L (≥50% of bone marrow nucleated cells are plasma cells).
- Patients whose expecting survival time will be more than 3 months.
- Without active infectious disease.
- Female patients of child-bearing potential must have a negative serum pregnancy test at screening and all patients agree to use two reliable methods of contraception for six months after their last dose of medication.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases.
- Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0.
- Plasma cell leukemia.
- Serious thrombotic events.
- Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b. Uncontrolled, clinically significant conduction abnormalities (except antiarrhythmic ventricular tachycardia), but patients with first-degree...
- Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)).
- Serum bilirubin≥1.5 × ULN.
- creatinine clearance \<30 ml/min.
- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma.
- Previous major operation within 30 days before C1D1.
- Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol.
- According to the study protocol or in the opinion of the investigator,serious physical or mental illness that is likely to interfere with the study procedures/results.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Current participation in another clinical trial.
- Pregnant or lactating women.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Changzhou, Jiangsu, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Taizhou, Jiangsu, China
- Yancheng, Jiangsu, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changzhou, Jiangsu, China; Nanjing, Jiangsu, China; Nantong, Jiangsu, China; Taizhou, Jiangsu, China; Yancheng, Jiangsu, 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.