Selinexor, Dexamethasone and Bortezomib in Patients with Multiple Myeloma
EU CTIS ID: 2024-511608-18-00
What this study is testing
To evaluate the efficacy of treatment in the 4 arms: - Selinexor 40 mg plus dexamethasone 20 mg in patients with pentarefractory multiple myeloma twice/week, - Selinexor 80 mg plus dexamethasone 20 mg in patients with pentarefractory multiple myeloma twice/week, - Selinexor 100 mg plus dexamethasone 40mg in patients with pentarefractory multiple myeloma once/week, - Selinexor 100 mg in combination with dexamethasone 40 mg and bortezomib 1.3 mg/m2 in patients with triple-class refractory multiple myeloma, once/week (without week 5 dosing).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years at the time of signing informed consent.
- Written informed consent signed in accordance with federal, local, and institutional guidelines.
- Measurable multiple myeloma (MM) based on International Myeloma Working Group (IMWG) guidelines as defined by at least one of the following: a. Serum M-protein ≥0.5 g/dL by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA. b. Urinary M-protein excretion ≥200 mg/24 hours. c. Free light chain (FLC) ≥100 mg/L, provided that the FLC ratio is abnormal.
- Only for Arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to PV 5.0: Patients must have RRMM and have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 PIs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody. Refractory is defined as ≤25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy. Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Patients must have RR MM and have been previously treated with ≥3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to at least 1 drug of each class (PI/IMiD/anti-CD38). Refractory is defined as ≤25% response to therapy or progression during therapy or progression within 60 days after completion of therapy.
- Only for arm SVd: Patients must have previously received 1 to 5 anti- MM prior therapies and have MM that is refractory to previous treatment with at least 1 PI, at least 1 IMiD, and 1 anti-CD38 monoclonal antibody.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
You likely can't join if
- Active plasma cell leukemia.
- Inadequate hematopoietic function defined as the following: a. Absolute neutrophil count (ANC) <1,000/mm3 b. Platelet count <75,000/mm3 c. Hemoglobin (Hb) level <8.0 g/dL
- Life expectancy of <4 months, based on the opinion of the Investigator.
- Major surgery within 4 weeks prior to C1D1.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.
- Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.
See the full eligibility criteria
Who can join
- Age ≥18 years at the time of signing informed consent.
- Written informed consent signed in accordance with federal, local, and institutional guidelines.
- Measurable multiple myeloma (MM) based on International Myeloma Working Group (IMWG) guidelines as defined by at least one of the following: a. Serum M-protein ≥0.5 g/dL by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA. b. Urinary M-protein excretion ≥200 mg/24 hours. c. Free light chain (FLC) ≥100 mg/L, provided that the FLC ratio is abnormal.
- Only for Arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to PV 5.0: Patients must have RRMM and have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 PIs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody. Refractory is defined as ≤25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy. Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Patients must have RR MM and have been previously treated with ≥3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to at least 1 drug of each class (PI/IMiD/anti-CD38). Refractory is defined as ≤25% response to therapy or progression during therapy or progression within 60 days after completion of therapy.
- Only for arm SVd: Patients must have previously received 1 to 5 anti- MM prior therapies and have MM that is refractory to previous treatment with at least 1 PI, at least 1 IMiD, and 1 anti-CD38 monoclonal antibody.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.
What rules you out
- Active plasma cell leukemia.
- Inadequate hematopoietic function defined as the following: a. Absolute neutrophil count (ANC) <1,000/mm3 b. Platelet count <75,000/mm3 c. Hemoglobin (Hb) level <8.0 g/dL
- Life expectancy of <4 months, based on the opinion of the Investigator.
- Major surgery within 4 weeks prior to C1D1.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.
- Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.
- Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus RNA or hepatitis B virus surface antigen.
- Female patients who are pregnant or lactating.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at C1D1.
- Concurrent therapy with approved or investigational anticancer therapeutic including topical therapies.
- Prior exposure to a SINE compound, including selinexor.
- Documented systemic amyloid light chain amyloidosis.
- Serious, active psychiatric or active medical conditions which, in the opinion of the Investigator or the Sponsor, could interfere with participation in the study.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Active central nervous system MM.
- Only for Arm SVd: Greater than Grade 2 peripheral neuropathy or Grade ≥2 peripheral neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication.
- Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including investigational therapies) ≤2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids are permitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1.)
- Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
- Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade >2 at C1D1.
- Inadequate hepatic function defined as total bilirubin ≥2x upper limit of normal (ULN) (≥3x ULN for patients with Gilbert’s syndrome), aspartate transaminase (AST) ≥2.5x ULN, and alanine transaminase (ALT) ≥2.5x ULN.
- Inadequate renal function defined as estimated creatinine clearance of <20 mL/min, calculated using the formula of Cockroft and Gault (Section 9.5.4).
The study team makes the final eligibility decision.
Where it's taking place
- Greece
- Israel
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, but 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greece; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.