Phase 3 Myeloma Trial, Recruiting NCT05561387 Sponsor: SWOG Cancer Research Network Condition: Myeloma
Back to Myeloma

Phase 3 Myeloma Trial, Recruiting

NCT05561387
Recruiting Phase 3

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, confirmed using standard diagnostic guidelines within the past 28 days
  • Your myeloma can be measured through blood or urine tests showing certain levels of abnormal proteins (confirm with trial site for specific values)
  • You have been scored as either "frail" or "intermediate fit" using a myeloma frailty calculator within the past 28 days
  • If scored as "frail," you have low but acceptable blood counts (red blood cells, platelets, and white blood cells) within the past 28 days — blood or platelet transfusions and growth factor support are allowed if your low counts are due to myeloma
  • If scored as "intermediate fit," you meet at least one of these: significantly reduced kidney function, low blood counts in certain ranges, or advanced-stage (stage III) myeloma — confirmed by tests within the past 28 days
  • If scored as "frail," you have some level of kidney problems but are NOT on dialysis
  • You have had a full body imaging scan (preferably a PET/CT scan) within the past 60 days
  • Your liver function blood tests are within an acceptable range within the past 28 days
  • Your heart is working well enough, as judged by your doctor within the past 14 days (if you have heart problems, they must not be severe)
  • If you have diabetes, it must be reasonably well controlled, shown by a recent blood test within the past 14 days
  • If you have HIV, you must be on anti-HIV medication and have an undetectable viral load on your most recent test (within the past 6 months)
  • If you have had hepatitis B, your virus levels must be undetectable while on treatment within the past 28 days
  • If you have had hepatitis C, you must have been successfully treated and cured, or currently have an undetectable viral load if still on treatment within the past 28 days
  • Your general health and ability to carry out daily activities is rated at a moderate level or better (confirm with trial site for exact scoring)
  • You are willing to have tissue/blood samples stored for research (with your consent)
  • You are willing to fill in questionnaires about how you are feeling (available in English or Spanish)
  • You have been told this is a research study and have signed a consent form (a legal representative may sign on your behalf if needed)

Who may not be able to join:

  • You have already received treatment for multiple myeloma, with limited exceptions: a short emergency course of steroids, up to one cycle of certain chemotherapy (not including daratumumab-based treatment), or completed radiotherapy to a specific area at least 3 days before starting the study treatment
  • You have severe nerve damage in your hands or feet (grade 4 peripheral neuropathy)
  • Your blood pressure has been too high (above 140/90) at any point in the 14 days before joining, and has not returned to normal
  • You have another cancer (past or present) that your doctor believes could interfere with this study's treatment or results
  • You are currently pregnant or breastfeeding
  • You are able to have children or father children and are not willing to use effective contraception during the study

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 3: approximately ~65% 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: Sikander Ailawadhi, SWOG Cancer Research Network

Phone: 210-614-8808

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 3
Sponsor
SWOG Cancer Research Network
Registry
ClinicalTrials.gov
Start date
12 October 2023
Est. completion
30 May 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2; Overall survival (OS) of Arm 1 vs. Arm 3

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