Phase 2 Myeloma Trial, Terminated NCT06160609 Sponsor: GlaxoSmithKline Condition: Myeloma
Back to Myeloma

Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT06160609) enrolled 9 people with multiple myeloma across two small groups: 6 participants received a lower dose combination (1.9 mg/kg of belantamab mafodotin plus 8 mg of a drug called OX40), and 3 participants received a higher dose combination (2.5 mg/kg of belantamab mafodotin plus the same OX40 dose). All 9 participants completed the study. The trial was in an early "dose exploration" phase, primarily looking at whether the drug combination caused serious dose-limiting side effects (that is, side effects severe enough to prevent continuing at that dose level), as well as tracking any adverse events (unwanted medical occurrences) and changes in blood test results. The reported data shows that no participants in either group experienced a dose-limiting toxicity. However, all 9 participants — all 6 in the lower-dose group and all 3 in the higher-dose group — experienced at least one adverse event of some kind. For blood test results, small numbers of participants showed worsening in some measures: for example, in the lower-dose group, changes were recorded in a small number of participants across various blood counts and chemistry markers, and similarly in the higher-dose group. The trial also measured how many participants' cancer responded to treatment (called the Overall Response Rate); the reported data shows a response rate of 0% in both groups during this dose-exploration phase. The reported data for the planned later "cohort expansion" phase of the trial — which was also supposed to report an Overall Response Rate — shows no measurements were submitted for that outcome, so those results were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Myeloma Trial, Terminated

NCT06160609
Terminated Phase 2 🇦🇺 Australian site

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 must be 18 years old or older at the time of signing the consent form.
  • You must have been diagnosed with Multiple Myeloma (MM) confirmed by a lab test (tissue or cell sample).
  • You must have already received at least 3 different previous treatments for myeloma, including one from each of these groups: an immunomodulating drug, a proteasome inhibitor, and an anti-CD38 antibody treatment.
  • If you have had a stem cell transplant using your own cells, you may still be eligible if the transplant was more than 100 days ago and you have no active infections.
  • You must be in reasonably good general health (able to carry out daily activities), unless any limitations are caused only by bone-related problems from your myeloma.
  • Your myeloma must be measurable through specific blood or urine test results showing certain protein levels above set thresholds (confirm with trial site for exact values).
  • If you have tested positive for a Hepatitis B antibody, you may still be eligible if other Hepatitis B markers are negative and the virus is undetectable in your blood during screening.
  • You may be eligible if you are currently taking low-dose oral steroids (less than 10mg per day), inhaled steroids, or eye drop steroids.

Who may not be able to join:

  • You may not be eligible if you have an active eye surface condition (other than a very mild form).
  • You may not be eligible if you have signs of certain heart or cardiovascular health risks (confirm with trial site for specifics).
  • You may not be eligible if you have had a serious allergic reaction to the study drug (belantamab mafodotin) or similar drugs, or a severe reaction to other antibody-type treatments.
  • You may not be eligible if you currently have an active infection being treated with antibiotic, antiviral, or antifungal medication.
  • You may not be eligible if you have received a similar antibody treatment within the last 30 days, or any other myeloma treatment within the last 14 days.
  • You may not be eligible if you have had radiation therapy within 2 weeks before starting the study.
  • You may not be eligible if you have previously received a stem cell transplant using someone else's cells (allogeneic transplant).
  • You may not be eligible if you received CAR-T cell therapy with chemotherapy as part of the preparation within the last 3 months.
  • You may not be eligible if you have had major surgery (not including bone-stabilising procedures) within the last 30 days.
  • You may not be eligible if you have taken part in another experimental treatment study within 14 days, or within 5 half-lives of that drug, whichever is shorter (confirm with trial site).
  • You may not be eligible if you had a severe side effect from a previous type of cancer treatment called a checkpoint inhibitor that caused you to stop that treatment.
  • You may not be eligible if you received a blood transfusion within 2 weeks before your first dose of the study drug.
  • You may not be eligible if you have received a live vaccine within 30 days before starting the study, or plan to receive one during or within 70 days after completing the study treatment.
  • You may not be eligible if you have an active kidney condition (such as an infection or need for dialysis), unless protein in the urine is caused by myeloma itself.
  • You may not be eligible if you have HIV, unless your HIV is well controlled on established treatment with specific blood count and viral load results meeting set criteria (confirm with trial site).
  • You may not be eligible if you have an autoimmune condition (current or past) that required ongoing medical treatment within the last 2 years.
  • You may not be eligible if you have had an episode of symptomatic pericarditis (inflammation around the heart causing symptoms) within the last 6 months.

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: GSK Clinical Trials, GlaxoSmithKline

Australian sites

GSK Investigational Site, Fitzroy, Victoria

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
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
7 October 2019
Est. completion
9 January 2023

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇸🇪 Sweden

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

DE Phase: Number of Participants With Dose Limiting Toxicities (DLT); DE Phase: Number of Participants With Adverse Events (AEs); DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline; DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline; Cohort Expansion (CE) Phase: Overall Response Rate (ORR)

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