Ixazomib Combo for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJoseph M. Tuscano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Joseph Tuscano

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of clarithromycin when given together with ixazomib citrate, pomalidomide, and dexamethasone and to see how well it works in treating patients with multiple myeloma that has not responded to previous treatment. Biological therapies, such as clarithromycin, pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clarithromycin with ixazomib citrate, pomalidomide and dexamethasone may be a better treatment for patients with multiple myeloma.

Eligibility Criteria

This trial is for patients with multiple myeloma that's gotten worse after treatment. They must have had a biopsy confirming the diagnosis, measurable disease, and be in fairly good health (ECOG status 0-2). Participants need to agree to use contraception and should not have other serious illnesses or recent treatments that could affect the study drugs' absorption or their own recovery.

Inclusion Criteria

I have been cancer-free for over 5 years, except for nonmelanoma skin cancer or carcinoma in situ which was fully removed.

I am following the required birth control measures.

Voluntary written consent

+8 more

Exclusion Criteria

I am not pregnant or breastfeeding.

I have not had major surgery in the last 14 days.

I have not had radiotherapy in the last 14 days.

+14 more

Participant Groups

The trial is testing clarithromycin combined with ixazomib citrate, pomalidomide, and dexamethasone on patients whose multiple myeloma has resisted previous treatments. It aims to find the safest dose of clarithromycin when used with these drugs and see how well this combination works against cancer cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (PiC-D therapy)Experimental Treatment4 Interventions

Patients receive pomalidomide PO QD on days 1-21; ixazomib citrate PO on days 1, 8, and 15; clarithromycin PO BID on days 15-21 of course 1 and days 1-21 of courses 2-6; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive pomalidomide, ixazomib citrate, and dexamethasone as above and receive clarithromycin PO BID or QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Clarithromycin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Biaxin for: