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Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT02477215 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-10-22

Study results available
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Summary

This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue to receive up to eight cycles total in the absence of further progressive disease.

Conditions

Interventions

DRUG

MLN9708

4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.

DRUG

Dexamethasone

40 mg oral on Days 1, 8, 15 of each 28 day cycle.

DRUG

Bendamustine (multiple dose levels)

70 mg/m\^2, 80 mg/m\^2, or 90 mg/m\^2 on days 1 and 2

DRUG

Bendamustine (MTD)

80 mg/m\^2 on days 1 and 2

Sponsors & Collaborators

  • Parameswaran Hari

    lead OTHER

Principal Investigators

  • Parameswaran Hari, MD, MRCP, MS · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-09
Primary Completion
2018-05-02
Completion
2020-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02477215 on ClinicalTrials.gov