Phase 2 Myeloma Trial, Recruiting NCT05597345 Sponsor: University of Rochester Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05597345
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:

  • People aged 18 years or older
  • People who have a confirmed diagnosis of smouldering multiple myeloma (SMM), a pre-cancer blood condition, based on specific laboratory findings showing abnormal protein levels or abnormal bone marrow plasma cell levels within a defined range
  • People whose condition does not currently cause symptoms such as high calcium levels, anaemia, bone damage, or kidney problems linked to the plasma cell disorder
  • People whose SMM is considered intermediate or high risk based on at least one or more specific blood and bone marrow measurements (confirm with trial site for exact thresholds)
  • People with normal liver function, confirmed by blood tests done within 28 days before starting the trial
  • People with adequate kidney function, confirmed by a specific calculation within 28 days before starting the trial
  • People with adequate blood cell counts (white cells, red cells, and platelets) within 28 days before starting the trial
  • People with a life expectancy of more than 12 months
  • People who are in good general health, able to carry out normal daily activities with little to no restriction (a standard medical performance score of 0 or 1)
  • People who are able to use two highly effective forms of contraception, or abstain from sex, throughout the trial and for 6 months after it ends (people who have had procedures making them unable to have children may be exempt)
  • People who are able to understand and agree to the trial requirements

Who may not be able to join:

  • People whose condition has progressed to active (symptomatic) multiple myeloma, indicated by high blood calcium, significant kidney problems, anaemia, bone lesions, very high levels of abnormal plasma cells in the bone marrow (60% or more), or very high abnormal protein levels in the blood
  • People with a condition called systemic light chain amyloidosis (a related protein disorder affecting organs)
  • People who regularly take corticosteroid medications (such as prednisone) at doses above 10mg per day for other health conditions
  • People who have had an active invasive cancer within the past 3 years that could affect the trial results
  • People who have had a non-invasive cancer within the past 3 years that was not treated with the aim of curing it, and that could affect the trial results
  • People with an uncontrolled active infection that required intravenous antibiotics, antiviral, or antifungal treatment within 14 days before the first dose
  • People with a known active HIV infection that is not being adequately managed with treatment
  • People with active digestive system problems that prevent swallowing tablets or interfere with how the body absorbs medications
  • People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after finishing treatment
  • People capable of having children who are not willing to use two highly effective forms of contraception during treatment and for 6 months after it ends
  • People with a significant medical or psychiatric condition that, in the opinion of the trial doctors, may prevent them from completing the trial or affect the results
  • People who have previously been treated with a type of drug called a SINE compound, including a drug called Selinexor

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 28 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: Jodi Lipof, University of Rochester

Phone: 6505042400

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
21 August 2023
Est. completion
29 October 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of progression to Multiple Myeloma

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: 28 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