Clinical trial for Relapsed and Refractory Multiple Myeloma
Official title Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05530421
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, taken by mouth, being studied as a potential treatment for relapsed and refractory multiple myeloma.
Also referred to as 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 research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).
- 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
- Anemia: Hemoglobin ≤10 g/dL, or
- Renal failure: serum creatinine ≥ 2.0 mg/dL, or
- Hypercalcemia: Ca ≥10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or Positron emission tomography/Computed Tomography (PET/CT), or
- ≥ 2 focal lesions on spinal magnetic resonance imaging (MRI), or
You likely can't join if
- Has received selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously.
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.)...
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1).
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Pregnant or breastfeeding females.
- Active, unstable cardiovascular function, as indicated by the presence of symptomatic ischemia, or Uncontrolled clinically significant conduction...
See the full eligibility criteria
- Anemia: Hemoglobin ≤10 g/dL, or
- Renal failure: serum creatinine ≥ 2.0 mg/dL, or
- Hypercalcemia: Ca ≥10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or Positron emission tomography/Computed Tomography (PET/CT), or
- ≥ 2 focal lesions on spinal magnetic resonance imaging (MRI), or
- ≥ 60% bone marrow plasma cells, or Involved/un-involved serum free light chain ratio ≥ 100. Age ≥18 years of age on day of signing informed consent.
- Patients must have had a bone marrow (BM) biopsy proven plasma cell myeloma harboring the t(11;14) translocation as reported by a Clinical Laboratory Improvement Amendments (CLIA) certified assay (i.e.
- Must have Relapsed or Relapsed and Refractory Multiple Myeloma. Patients must have documented evidence of having received two prior lines of therapy and be refractory to, not a candidate for (ineligible), or intolerant...
- Serum monoclonal protein ≥ 0.5 g/dl
- Urine monoclonal protein \>200 mg/24 hour
- Serum immunoglobulin free light chain \>10 mg/dL AND abnormal kappa/lambda ratio
- Bone marrow plasma cells ≥ 30%
- A measurable lesion on PET/CT or MRI ≥ 2 cm
- Be ≥ 18 years of age on day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 3 (Appendix A)
- Absolute neutrophil count (ANC) 1000/microliter (mcL) (granulocyte-colony stimulating factor (G-CSF) allowed)
- Platelets ≥ 50,000/mcL (transfusions and stimulators permitted); in patients with \>50% bone marrow plasma cells, platelets ≥ 30,000/mcL
- Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or calculated creatinine clearance (CrCl)/Estimated glomerular filtration rate (eGFR) (by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification...
- Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 X ULN)
- Aspartate transaminase (SGOT) and alanine transaminase (SGPT) ≤ 2.5 X ULN
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing...
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- Has received selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously.
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1).
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Pregnant or breastfeeding females.
- Active, unstable cardiovascular function, as indicated by the presence of symptomatic ischemia, or Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on...
- people with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for \>8 weeks and viral load is \<100 IU/ml prior to first dose of trial treatment.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO)...
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Patients unwilling or unable to comply with the protocol or known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the...
The study team makes the final eligibility decision.
Where it is enrolling
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Coral Gables, Florida, United States; Deerfield Beach, Florida, United States; Miami, Florida, United States. Enter your location above to see the nearest enrolling 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 ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.