Phase 2 Myeloma Trial, Recruiting NCT06115135 Sponsor: Oncotherapeutics Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT06115135
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:

  • You have been diagnosed with multiple myeloma (a type of blood cancer affecting plasma cells in the bone marrow), confirmed by standard medical tests
  • Your myeloma is currently active and measurable through blood or urine tests showing abnormal protein levels
  • Your myeloma cells have a specific genetic change called the (11;14) translocation, confirmed by a laboratory test called FISH or chromosomal analysis
  • Your blood counts are at acceptable levels: white blood cells (neutrophils) at least 1.5, platelets at least 75, and hemoglobin at least 8.0 g/dL within the past 3 weeks
  • Your kidneys are working well enough, with a kidney function score of at least 30 mL/minute
  • Your liver test results (bilirubin, AST, ALT) are at or near normal levels
  • Your blood potassium level is within the normal range (3.0–5.5 mEq/L)
  • You are generally able to carry out some daily activities (your doctor has rated your overall health status as 0, 1, or 2 on a standard scale)
  • You have already received at least one prior treatment for multiple myeloma, which must have included a proteasome inhibitor, lenalidomide, and a steroid medication
  • Your myeloma has been confirmed to be getting worse (progressing) according to standard medical guidelines
  • If you are a woman who could become pregnant, you must be willing to use two forms of birth control at the same time, starting at least 28 days before treatment, and agree to regular pregnancy tests; contraception must continue for 3 months after treatment ends
  • If you are a man, you must agree to use a condom during sexual contact with a woman who could become pregnant, even if you have had a vasectomy

Who may not be able to join:

  • You have previously had a bad reaction or intolerance to any of the medications used in this trial
  • You have certain other serious conditions, including a protein build-up disorder (amyloidosis), a rare nerve and organ disorder called POEMS syndrome, HIV infection, active hepatitis B or C, serious heart problems (such as uncontrolled chest pain, severe irregular heartbeat, a heart attack within the last 6 months, or significant heart failure), major surgery in the last 4 weeks, a serious active infection requiring IV treatment in the last 2 weeks, uncontrolled diabetes or high blood pressure in the last 2 weeks, or any other condition your doctor feels would make participation unsafe
  • You have had another active cancer in the past 3 years, unless it was fully treated and removed with no signs of return, and is unlikely to affect your survival during the study
  • You previously had a bone marrow transplant using donor cells and still have signs of graft-versus-host disease (where the donor cells are attacking your body)
  • You are currently pregnant or breastfeeding
  • You have a known allergy to any of the study medications or their ingredients
  • You received an anti-CD38 antibody treatment (such as daratumumab or isatuximab) within the last 3 weeks
  • You were previously treated with an anti-CD38 antibody (daratumumab or isatuximab) and your myeloma did not show at least a minimal response to it
  • You have previously been treated with venetoclax (one of the drugs being studied)
  • You received chemotherapy, high-dose steroids, immunotherapy, or certain other cancer treatments within the last 3 weeks before starting the study
  • You received extensive radiation therapy within the last 28 days (targeted local radiation may still be acceptable — confirm with trial site)
  • You participated in another experimental drug study within the last 28 days
  • You have taken certain medications that affect how the body processes drugs (called CYP3A inhibitors or inducers) within the last 7 days
  • You have eaten grapefruit, Seville oranges (including marmalade), or star fruit within 3 days before starting the study drugs
  • You are currently taking certain medications including warfarin (a blood thinner) or other drugs that may interact with the study medications (confirm with trial site)

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 5 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: 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 2
Sponsor
Oncotherapeutics
Registry
ClinicalTrials.gov
Start date
20 June 2024
Est. completion
30 April 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events [Safety]; Overall response rate (ORR) as a measure of efficacy; Clinical benefit rate (CBR) as a measure of efficacy

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: 5 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