NCT05530421 · University of Miami
Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma
(SELVEDge)
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Selinexor
Selinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
DRUG
Venetoclax
Venetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
DRUG
Dexamethasone
Dexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
Primary outcome measures
Fraction of Participants Achieving Overall Response
Time frame: Up to 3 years
Overall response rate (ORR) will be reported as the fraction of participants achieving either complete response (CR) or partial response (ORR = CR + PR) to study treatment. Response to therapy will be assessed by treating physician using International Myeloma Working Group 2016 response criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG).5 Patients at initial diagnosis must have had a serum M-protein ≥ 3 g/dL and/or bone marrow plasma cells ≥10%, and at least one of the following: 1. Anemia: Hemoglobin ≤10 g/dL, or 2. Renal failure: serum creatinine ≥ 2.0 mg/dL, or 3. Hypercalcemia: Ca ≥10.5 mg/dL, or 4. Lytic bone lesions on X-ray, CT, or Positron emission tomography/Computed Tomography (PET/CT), or 5. ≥ 2 focal lesions on spinal magnetic resonance imaging (MRI), or 6. ≥ 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. 2. 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. local fluorescence in situ hybrid
Where
- Coral Gables, Florida
- Deerfield Beach, Florida
- Miami, Florida
Collaborators
Karyopharm Therapeutics Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations