Study on Ixazomib, Pomalidomide, and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Sponsor: Omar Nadeem, MD

Sponsor score: 0

Inactive

ClinicalTrials ID:NCT04094961

This clinical trial is testing a combination of three drugs—ixazomib, pomalidomide, and dexamethasone—to see if they can safely and effectively treat patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

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Program Overview

This study is exploring a new treatment for patients with multiple myeloma, a type of blood cancer, that has either come back or not responded to previous treatments. The trial is in two phases: Phase I focuses on finding the safest dose of the drug combination, while Phase II looks at how well the treatment works. The drugs being tested are ixazomib, pomalidomide, and dexamethasone, all of which are already approved for treating multiple myeloma individually. Researchers hope that using them together will improve treatment outcomes.

Description

Ixazomib works by blocking a part of the cell called the proteasome, which is more active in myeloma cells. This blockage can lead to the death of these cancer cells. Pomalidomide also helps kill cancer cells, and dexamethasone, a steroid, can enhance the effects of other cancer drugs by reducing inflammation and immune responses.

The study aims to determine the highest safe dose of ixazomib when used with pomalidomide and dexamethasone. All three drugs are already approved for treating multiple myeloma, but this study is testing their combined use to see if it offers better control of the disease.

Eligibility Criteria

Inclusion Criteria

Have relapsed or refractory multiple myeloma and meet all entry criteria.
Previously diagnosed with multiple myeloma and currently need treatment.
Have given written informed consent to participate in the study.
Have received at least two previous treatments, or one prior treatment if it included an IMiD and a proteasome inhibitor, and the disease progressed within 60 days of the last treatment.
Have measurable disease based on specific medical criteria.
Meet certain blood test requirements, including:
- Neutrophil count of at least 1,000 cells/dL.
- Platelet count of at least 75,000 cells/dL.
- Hemoglobin level of at least 8.0 g/dL.
- Total bilirubin within specified limits.
- Liver enzymes (AST and ALT) within specified limits.
- Kidney function within specified limits.
Have an ECOG performance status of 2 or less.
Be registered in the POMALYST REMS® program and comply with its requirements.
Women of childbearing potential must adhere to pregnancy testing as required by the POMALYST REMS® program.
Be able to understand and sign a written informed consent document.

Exclusion Criteria

Have previously been treated with ixazomib or are resistant to pomalidomide.
Participated in other clinical trials within 30 days of starting this trial.
Diagnosed or treated for another cancer within 3 years, except for certain skin cancers or low-risk prostate cancer.
Have gastrointestinal issues that affect drug absorption.
Have central nervous system involvement.
Have used certain medications within 14 days before starting the trial.
Have serious medical or psychiatric conditions that could affect participation.
Have uncontrolled heart conditions.
Have received certain treatments within specified time frames before starting the trial.
Have active graft versus host disease.
Have had major surgery or radiation therapy within 14 days of starting the trial.
Require daily corticosteroids above a certain dose.
Have certain blood disorders or infections.
Are pregnant or breastfeeding.
Have a history of severe allergic reactions to similar drugs.
Cannot tolerate blood clot prevention measures.
Have not fully recovered from previous chemotherapy side effects.
Have unresolved peripheral neuropathy above a certain level.

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