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Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma

NCT03856112 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-03-26

No results posted yet for this study

Summary

This phase I/II trial studies the best dose and side effects of venetoclax and how well it works in combination with ixazomib and dexamethasone in treating patients with t(11;14) negative multiple myeloma that has come back or does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and 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. It is not yet known how well venetoclax works with ixazomib and dexamethasone in treating patients with multiple myeloma.

Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
  • t(11;14) Negative

Interventions

DRUG

Dexamethasone

Given PO

DRUG

Ixazomib

Given PO

DRUG

Ixazomib Citrate

Given PO

DRUG

Venetoclax

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Taiga Nishihori · University Health Network Princess Margaret Cancer Center LAO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856112 on ClinicalTrials.gov