Phase 1 Myeloma Trial, Recruiting NCT06225310 Sponsor: Oncotherapeutics Condition: Myeloma
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Phase 1 Myeloma Trial, Recruiting

NCT06225310
Recruiting Phase 1

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 who have been diagnosed with multiple myeloma (MM) based on standard medical criteria, including having a certain level of abnormal plasma cells in the bone marrow or a proven tumour made of plasma cells
  • People whose myeloma has been confirmed as "active," meaning it is causing harm to the body — such as high calcium levels in the blood, kidney problems, low red blood cell levels (anaemia), or bone damage — or who meet other specific laboratory or imaging findings showing active disease
  • People whose myeloma has come back or stopped responding to treatment, and who have already gone through at least three separate rounds (lines) of treatment
  • People who have previously been treated with all three of the following types of therapy: an anti-CD38 antibody treatment, an immunomodulatory drug (IMiD), and a proteasome inhibitor (PI)
  • People whose myeloma is currently detectable through specific blood, urine, or imaging tests (measurable disease)
  • People whose myeloma is currently progressing — either returning more than 60 days after their last treatment ended, or failing to respond while on treatment or within 8 weeks of stopping it
  • People whose liver is working well enough, based on blood tests done within 14 days before starting the trial
  • People whose kidneys are working well enough, based on a calculated kidney function score above a certain level, tested within 14 days before starting
  • People whose blood cell counts (white blood cells, red blood cells, and platelets) are at or above certain minimum levels, tested within 14 days before starting
  • People who have had recent blood-boosting injections (such as growth factor support) must have waited at least 2 weeks before screening tests, though these may continue during the trial
  • People who have had a recent red blood cell transfusion must have waited at least 2 weeks, and those who have had a platelet transfusion must have waited at least 1 week, before starting study treatment
  • Women who could become pregnant must have a negative pregnancy test before starting, and both women who could become pregnant and fertile men must agree to use highly effective contraception throughout the trial and for one month after the last dose; men must also agree not to donate sperm during treatment
  • People who are able to take blood-thinning or antiplatelet medication (such as aspirin or similar medicines) if their platelet count is above a certain level
  • People living with HIV may be eligible if their immune cell count is at or above a certain level, their viral load is undetectable, and they have not had a serious HIV-related infection in the past year
  • People with untreated hepatitis C may be eligible if their viral load is shown to be undetectable
  • People aged 18 or older
  • People who are willing and able to give written informed consent before any screening begins
  • People who are able to follow the trial visit schedule and meet all study requirements

Who may not be able to join:

  • People who have previously been treated with ruxolitinib or selinexor
  • People who have had another cancer in the past 3 years that required treatment or has come back (skin cancers that are not melanoma and certain cervical conditions may be exceptions; cancers treated with the intent to cure more than 5 years ago with no signs of return may also be considered)
  • People who have light chain amyloidosis (a condition where abnormal proteins build up in organs)
  • People who have plasma cell leukaemia (a more aggressive blood cancer related to myeloma)
  • People with a history of active tuberculosis
  • People with other serious ongoing medical conditions — such as uncontrolled high blood pressure, uncontrolled diabetes, active widespread infection, or certain rare conditions like POEMS syndrome or primary amyloidosis — that could interfere with the study
  • People with an active serious infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment within 1 week before the first treatment day (people on preventive antibiotics or with a controlled infection may still be considered)
  • People who have received chemotherapy within 3 weeks before study treatment
  • People who have taken high-dose steroids (above a certain daily amount) within 3 weeks before study treatment
  • People who have received immunotherapy, immunomodulatory drugs, or proteasome inhibitors within 3 weeks before study treatment
  • People who have had extensive radiation therapy within 28 days before study treatment (localised radiation therapy may not be a barrier — confirm with trial site)
  • People who have taken another experimental drug or treatment within 28 days before study treatment
  • People who have taken certain medications that strongly affect how the body processes drugs (specific enzyme inhibitors or inducers, or high-dose fluconazole) within a defined washout period before study treatment
  • People who are known to have an intolerance, allergy, or medical reason to avoid steroid medications
  • People who are known to have an allergy or sensitivity to medications similar in makeup to ruxolitinib or steroids
  • People who are currently receiving other cancer treatments at the same time
  • People with severely high calcium levels in the blood above a certain threshold
  • People with any condition or abnormal test result that would put them at unacceptable risk by taking part, or that would make the study results hard to interpret
  • Women who are pregnant or breastfeeding
  • People with a body surface area (a measure of body size) below a minimum threshold at the start of the trial
  • People with a life expectancy of less than 3 months
  • People who have had major surgery within 4 weeks before the first treatment day
  • People with active, unstable heart or cardiovascular problems — including chest pain from reduced blood flow, serious uncontrolled heart rhythm problems, moderate-to-severe heart failure, a recent heart attack within 3 months, or a stroke or blood clot (such as a pulmonary embolism or deep vein thrombosis) within 3 months
  • People with active digestive system problems that would prevent them from swallowing tablets or absorbing the study medication properly
  • People who are unwilling or unable to take recommended supportive medications, such as anti-nausea treatments
  • People with serious active psychiatric or other medical conditions that, in the view of the trial doctor, could interfere with safe participation or the ability to give informed consent
  • People who have a medical reason to avoid any of the required supportive medications used alongside the study treatment
  • People who are unwilling or unable to follow the trial requirements

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 12 July 2026
Phase 1: approximately ~10% 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: James Berenson, MD, Oncotherapeutics

Phone: 310-464-2190

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 1
Sponsor
Oncotherapeutics
Registry
ClinicalTrials.gov
Start date
6 August 2024
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

1. Maximum Tolerated Dose (MTD):; 2. Recommended phase 2 dose (RP2D)

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: 12 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