Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Mayo Clinic
Study ID
NCT03399539
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Plasma Cell Myeloma
  • T(11;14)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given PO
  • Ixazomib Citrate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Venetoclax — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with ixazomib citrate and dexamethasone may work better in treating patients with multiple myeloma.

Key Dates

Start date
May 2, 2018
Status verified
Oct 2024
Primary completion
Dec 20, 2021
Completion
Feb 23, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, ixazomib citrate, dexamethasone)
    Patients receive venetoclax PO daily on days 1-28, ixazomib citrate PO once weekly on days 1, 8, and 15, and dexamethasone PO on days 1, 8, 15, and 22 for courses 1-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of venetoclax in combination with ixazomib and dexamethasone (Phase 1) [ Time Frame: Up to 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-
Siteman Cancer Center at Washington UniversitySt LouisMissouri63110-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MIMayo Clinic· Rochester, MNSiteman Cancer Center at Washington University· St Louis, MO

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