Phase 2 Myeloma Trial, Recruiting NCT05789303 Sponsor: University of Chicago Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05789303
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 are 18 years of age or older.
  • People whose doctors estimate they have a life expectancy of more than three months.
  • People who are well enough to carry out basic daily activities, as measured by a standard cancer performance scale (a score of 0, 1, or 2 on the ECOG scale — confirm with trial site if unsure what this means).
  • People whose liver, kidneys, and other organs are functioning at a level acceptable to the study team, based on blood test results.
  • People who have multiple myeloma that has come back or stopped responding to treatment, and who have already been through at least two prior rounds of treatment for their myeloma.
  • People who have previously been treated with certain myeloma medicines, including lenalidomide, bortezomib, daratumumab, elotuzumab, pomalidomide, and/or carfilzomib.
  • People who have NOT previously had CAR T-cell therapy and whose myeloma stopped responding to either carfilzomib or pomalidomide — but not both at the same time.
  • People whose most recent treatment WAS a specific type of CAR T-cell therapy targeting a protein called BCMA, and whose myeloma has since progressed — regardless of how their myeloma responded to carfilzomib or pomalidomide previously.
  • People whose myeloma can be measured through specific blood, urine, or protein tests that meet the levels set out by the study team.
  • People whose side effects from previous cancer treatments have mostly resolved (settled to a mild level), with the exception of hair loss and mild nerve-related symptoms, which are allowed.
  • People who are able to understand the study and are willing to give written consent to participate.
  • People who are willing to follow the safety program requirements linked to two of the study drugs, belantamab mafodotin and pomalidomide.
  • People whose insurance has approved coverage for pomalidomide and dexamethasone.
  • Female participants who are willing to follow local guidelines on contraception during clinical trials.
  • Male participants who agree to avoid donating sperm and to follow local contraception guidelines — including using a condom (even after a vasectomy) or remaining abstinent — during the treatment period and for six months after the last dose.

Who may not be able to join:

  • People who have certain other blood or plasma cell conditions, such as Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukaemia.
  • People who have had radiation treatment to multiple areas of the body within the three weeks before starting the trial (radiation to a single site at least one week before may be acceptable — confirm with trial site).
  • People who have taken any other experimental drug or standard myeloma treatment, including steroids, within 14 days before the first dose of the trial drug.
  • People whose myeloma previously stopped responding to belantamab mafodotin.
  • People with active corneal eye disease beyond very mild changes (confirm with trial site).
  • People with unstable liver or bile duct disease, such as fluid build-up in the abdomen, confusion related to liver failure, jaundice, or cirrhosis.
  • People with an active kidney condition, including kidney infection or the need for dialysis, that could affect their safety during the trial.
  • People who wear contact lenses, unless an eye specialist specifically advises otherwise during the trial.
  • People who are currently enrolled in another interventional clinical trial.
  • People who have had major surgery within two weeks before starting the trial.
  • People with any signs of active bleeding from body surfaces or internal organs.
  • People with significant nerve damage or nerve pain (grade 3–4, or grade 2 with pain) at the time of starting the trial.
  • People with certain serious or uncontrolled heart conditions, including uncontrolled irregular heartbeat, a heart attack or certain heart procedures within the past three months, severe heart failure (Class III or IV), or uncontrolled high blood pressure.
  • People who have had a known allergic or serious reaction to belantamab mafodotin or chemically similar drugs, or to any component of the study treatment.
  • People with an active infection that requires treatment.
  • People living with HIV, unless specific criteria related to immune cell levels, viral load, and overall health are met — as assessed by the study doctor.
  • People with Hepatitis B, unless specific clinical criteria confirmed by the study doctor are met.
  • People with an active or unresolved Hepatitis C infection, unless they have successfully completed antiviral treatment and meet specific testing requirements (confirm with trial site).
  • People with another active cancer, unless the second cancer has been medically stable for at least two years and is not expected to interfere with the study. People with certain treated skin cancers may be eligible without the two-year waiting period (confirm with trial site).
  • People who are pregnant or breastfeeding.
  • People with serious or unstable medical or psychiatric conditions that could affect their safety, their ability to give informed consent, or their ability to follow the study 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 23 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: Benjamin Derman, MD, University of Chicago

Phone: 1-855-702-8222

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
30 May 2023
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort); Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)

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: 23 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