Phase 2 Myeloma Trial, Recruiting NCT07099391 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT07099391
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 who have been diagnosed with multiple myeloma (a type of blood cancer) confirmed by standard diagnostic criteria, with signs that the cancer is active and measurable through blood tests, urine tests, bone marrow samples, or imaging scans taken within the past 4 weeks
  • People whose myeloma is classified as "standard risk," meaning certain high-risk genetic changes in the cancer cells are not present (confirm with trial site for full details on which genetic markers are assessed)
  • People who have been newly diagnosed with multiple myeloma and whose medical team considers them a suitable candidate for high-dose chemotherapy followed by a stem cell transplant using their own cells
  • People who have already received one complete cycle of a specific treatment combination called Dara-RVd at the trial's institution may be eligible to enter at cycle 2, at the treating doctor's discretion
  • People aged 18 years or older
  • People with a general health and activity level that falls within an acceptable range on a standard medical scale (rated 0 to 2 out of 4, meaning able to carry out normal daily activities or limited only in physically strenuous activity)
  • People whose blood counts and organ function (including kidneys, liver, and blood cells) meet minimum levels as determined by blood tests
  • People who are able to take one of the following blood-thinning or clot-prevention medicines: aspirin, low molecular weight heparin, warfarin, or a direct-acting oral anticoagulant
  • People who are willing and able to follow all requirements of a mandatory safety monitoring program called REMS®, including following required contraception methods

Who may not be able to join:

  • People who have already received more than one full cycle of treatment for their multiple myeloma (not counting steroids or radiation therapy alone)
  • People diagnosed with related but distinct conditions, including plasma cell leukaemia, light chain amyloidosis, MGUS (a pre-cancerous condition), smouldering myeloma, POEMS syndrome, or Waldenström's macroglobulinaemia
  • People who have had another active cancer within the past 2 years, with the exception of certain treated skin cancers or carcinoma in situ
  • People with serious uncontrolled health conditions that could interfere with the study, including:
    • Severe chronic lung disease (COPD) with significantly reduced lung function
    • Moderate to severe persistent asthma, or asthma that is not well controlled, in the past 2 years
    • A lung disease involving scarring or abnormal tissue in the lungs
    • An active autoimmune disease requiring immune-suppressing medication in the 6 months before starting the study (certain exceptions apply — confirm with trial site)
    • Serious psychiatric conditions, severe dementia, or significantly altered mental state, including alcohol or drug abuse
    • A known history of HIV
    • Active or unresolved hepatitis B infection (specific blood test results will determine eligibility — confirm with trial site)
    • Active hepatitis C infection that has not been successfully treated (confirm with trial site)
    • Significant heart problems, including a heart attack within the past 6 months, uncontrolled heart failure, severe chest pain, or uncontrolled irregular heartbeat
  • People who are pregnant or breastfeeding
  • People who are unwilling or unable to give informed consent, participate fully, or follow the study requirements for its entire duration

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 26 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: Neha Korde, MD, Memorial Sloan Kettering Cancer Center

Phone: 646-608-3708

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
24 July 2025
Est. completion
24 July 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase I: Toxicity; Phase II: MRD Negativity

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: 26 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