BridgeMD
New treatment option for Multiple Myeloma, Refractory
Official title A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
ClinicalTrials.gov ID: NCT04414475
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple myeloma, refractory.
Also referred to as KPT-330, XPOVIO.
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 assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.
- 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 and older
You may be able to join if
- Age greater than or equal to (\>=)18 years at the time of signing informed consent.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Measurable MM based on IMWG guidelines as defined by at least one of the following:
- Serum M-protein \>= 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.
- Urinary M-protein excretion \>= 200 mg/24 hours.
You likely can't join if
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active central nervous system MM.
- Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade \>= 2 peripheral neuropathy with pain at baseline, regardless of whether or not...
- Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including investigational therapies) \<= 2 weeks prior to Cycle 1 Day 1...
- Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
See the full eligibility criteria
- Age greater than or equal to (\>=)18 years at the time of signing informed consent.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Measurable MM based on IMWG guidelines as defined by at least one of the following:
- Serum M-protein \>= 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.
- Urinary M-protein excretion \>= 200 mg/24 hours.
- Free light chain (FLC) \>= 100 milligram per liter (mg/L), provided that the FLC ratio is abnormal.
- Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to protocol version (PV) 5.0: Participants must have relapsed or refractory multiple myeloma (RRMM) and have previously received at least 4 anti-MM prior therapies...
- Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Participants 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...
- Only for arm SVd: Participants 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 participants of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of...
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active central nervous system MM.
- Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade \>= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant 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...
- Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
- Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade greater than (\>) 2 at C1D1.
- Inadequate hepatic function defined as total bilirubin \>= 2x upper limit of normal (ULN) (\>= 3x ULN for participants with Gilbert's syndrome), aspartate transaminase (AST) \>= 2.5x ULN, and alanine transaminase (ALT)...
- Inadequate renal function defined as estimated creatinine clearance of lesser than (\<) 20 milliliter per minute (mL/min), calculated using the formula of Cockroft and Gault.
- Inadequate hematopoietic function defined as the following:
- Absolute neutrophil count (ANC) \< 1000/cubic millimeter (mm\^3)
- Platelet count \< 75,000/mm\^3
- Hemoglobin (Hb) level \< 8.5 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 participants 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.
- Serious, active psychiatric or active medical conditions which, in the opinion of the Investigator or the Sponsor, could interfere with the participation in the study.
- Contraindication to any of the required concomitant drugs or supportive treatments.
The study team makes the final eligibility decision.
Where it's taking place
- Pátrai, Achaia, Greece
- Attiki, Athens, Greece
- Athens, Attica, Greece
- Thessaloniki, Thessaloniki, Greece
- Afula, Afula, Israel
- Ashdod, Ashdod, Israel
- Haifa, Haifa District, Israel
- Jerusalem, Jerusalem, Israel
- Petah Tikva, Petah Tikva, Israel
- Ramat Gan, Ramat Gan, Israel
- Tel Aviv, Tel Aviv, Israel
- Ashkelon, Israel
- Beersheba, Israel
- Kfar Saba, 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 - 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 Pátrai, Achaia, Greece; Attiki, Athens, Greece; Athens, Attica, Greece; Thessaloniki, Thessaloniki, Greece; Afula, Afula, Israel; Ashdod, Ashdod, Israel and 8 more location(s). 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.