Study on Ixazomib with Pomalidomide, Clarithromycin, and Dexamethasone for Treating Multiple Myeloma

Sponsor: Joseph Tuscano

Sponsor score: 0

ClinicalTrials ID:NCT02542657

This clinical trial is testing a combination of drugs, including ixazomib, pomalidomide, clarithromycin, and dexamethasone, to find the best dose and see how well they work together in treating multiple myeloma that hasn't responded to previous treatments.

Patient Parameters

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Program Overview

The purpose of this study is to determine the best dose and effectiveness of a combination of drugs—ixazomib, pomalidomide, clarithromycin, and dexamethasone—in treating multiple myeloma that hasn't responded to other treatments. These drugs may help stop cancer cells from growing by boosting the immune system and blocking certain enzymes needed for cancer cell growth. The study aims to find out if this combination can be a better treatment option for patients with multiple myeloma.

Description

This study is divided into two phases: Phase I and Phase II.

In Phase I, researchers will determine the safest and most effective dose of the drug combination (ixazomib, pomalidomide, clarithromycin, and dexamethasone) for patients with multiple myeloma that hasn't responded to previous treatments. They will also evaluate the safety and how the drugs are processed in the body.

In Phase II, the study will focus on how well the treatment works in shrinking the cancer and improving patients' quality of life. Researchers will also look at how long the treatment keeps the cancer under control and how it affects patients' overall survival.

Patients will take pomalidomide daily for 21 days, ixazomib on specific days, clarithromycin twice daily during certain periods, and dexamethasone on specific days. This treatment cycle repeats every 28 days for up to 6 cycles, as long as the cancer doesn't progress and side effects are manageable.

After completing the main treatment, patients may continue with maintenance therapy, which involves taking the same drugs but possibly at different doses or schedules. Patients will be monitored every 2-3 months for up to 3 years after treatment.

Eligibility Criteria

Inclusion Criteria

Must provide written consent to participate.
Have a confirmed diagnosis of multiple myeloma.
Have measurable disease based on specific medical criteria.
The disease must have worsened during or shortly after treatment with certain other drugs (bortezomib and lenalidomide).
Have a life expectancy of more than 3 months.
Be in good overall health with a performance status of 0, 1, or 2.
Have been free of other cancers for more than 5 years, except for certain skin cancers or in situ cancers that have been completely removed.
Have adequate blood cell counts and organ function based on specific medical tests.
Women must not be pregnant and must agree to use effective birth control during and after the study.
Men must agree to use effective birth control during and after the study.

Exclusion Criteria

Women who are pregnant or breastfeeding.
Recent treatment with clarithromycin or other anti-myeloma therapies.
Have not fully recovered from previous chemotherapy.
Recent major surgery or radiation therapy.
Have cancer that has spread to the brain or spinal cord.
Have an active infection requiring treatment.
Have uncontrolled heart conditions or recent heart attack.
Are taking certain medications that affect how the study drugs work.
Have active hepatitis B, C, or HIV infections unless well-controlled.
Have serious medical or psychiatric conditions that could interfere with the study.
Have allergies to any of the study drugs.
Have severe nerve damage or difficulty swallowing.

Locations

FACILITY	ZIP	CITY	STATE
University of California San Diego	92093-0960	La Jolla	California
University of California Irvine	92868	Orange	California
University of California Davis Comprehensive Cancer Center	95817	Sacramento	California

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