Phase 2 Myeloma Trial, Recruiting NCT05530421 Sponsor: University of Miami Condition: Myeloma
Back to Myeloma

Phase 2 Myeloma Trial, Recruiting

NCT05530421
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with multiple myeloma (a type of blood cancer) according to standard medical guidelines, and at diagnosis had certain markers in your blood or bone marrow, plus at least one complication such as low red blood cells (anemia), reduced kidney function, high calcium levels, or bone damage seen on scans.
  • Your bone marrow biopsy has confirmed a specific genetic change in your myeloma cells called the t(11;14) translocation, detected by an approved laboratory test.
  • Your myeloma has come back (relapsed) or stopped responding to treatment (refractory), and you have already received at least two prior treatments — including at least one from each of these groups: immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 antibody treatments.
  • Your myeloma is still measurable through blood, urine, bone marrow, or scan results taken within the last 4 weeks before joining the trial.
  • You are 18 years of age or older at the time you sign the consent form.
  • You are well enough to carry out some daily activities, based on a standard health performance scale (confirm with trial site).
  • Your blood counts, kidney function, and liver function meet minimum levels shown by recent lab tests (confirm with trial site for exact values).
  • If you are a woman who could become pregnant, you have a negative pregnancy test before starting the trial, and both you and your partner (if applicable) agree to use highly effective contraception during the trial and for 90 days after the last dose.
  • You are willing and able to give written informed consent before any screening begins.

Who may not be able to join:

  • You have previously taken selinexor or a similar drug in the same class (called SINE compounds).
  • You have another serious medical condition that is not well controlled (such as uncontrolled high blood pressure, uncontrolled diabetes, or an active serious infection) that could interfere with the study.
  • You have an active infection requiring intravenous antibiotics, antivirals, or antifungal medicines within one week before starting the trial (those on preventive antibiotics or with a controlled infection may still be eligible — confirm with trial site).
  • You have a known allergy, intolerance, or medical reason why you cannot take steroid medications (glucocorticoids).
  • You are currently pregnant or breastfeeding.
  • You have unstable or serious heart problems, such as chest pain from reduced blood flow, a serious uncontrolled irregular heartbeat, significant heart failure, or a heart attack within the past 3 months.
  • You have active hepatitis B that has not been treated for long enough, or HIV with a low immune cell count or a recent serious HIV-related infection (those with well-controlled hepatitis B, untreated hepatitis C, or well-managed HIV may still be eligible — confirm with trial site).
  • You have a stomach or digestive problem that makes it difficult or impossible to swallow tablets or absorb medication properly.
  • You are unwilling or unable to take recommended supportive medications to help manage side effects such as nausea or loss of appetite.
  • You have a serious psychiatric or other medical condition that, in the doctor's opinion, would make it unsafe or impractical for you to take part.
  • You have a known allergy or medical reason preventing you from taking other required medications used alongside the trial treatment.
  • You are unable or unwilling to follow the trial requirements, or have a physical or mental condition that the doctor feels would make your participation unsafe or affect the trial results.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dickran Kazandjian, MD, University of Miami

Phone: 305-243-7701

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
26 March 2023
Est. completion
26 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Fraction of Participants Achieving Overall Response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov