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Dovitinib Combined With Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma

NCT01680796 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-02-20

No results posted yet for this study

Summary

This is an open-label phase I study in which dovitinib is given in combination with bortezomib and dexamethasone. Dovitinib dose escalation is planned in order to determine its maximum tolerated dose when given in this combination.

Conditions

Interventions

DRUG

Dovitinib

Dose Level 0: 200 mg daily Dose Level 1: 300 mg daily Dose Level 2: 300 mg daily Dose Level 3: 400 mg daily Dose Level 4: 500 mg daily

DRUG

Bortezomib

Dose Level 0: 1.3 mg/m2 IV on days 1 and 8 Dose Level 1: 1.3 mg/m2 IV on days 1 and 8 Dose Level 2: 1.6 mg/m2 IV on days 1 and 8 Dose Level 3: 1.6 mg/m2 IV on days 1 and 8 Dose Level 4: 1.6 mg/m2 IV on days 1 and 8

DRUG

Dexamethasone

Dexamethasone 20 mg will be given orally on Days 1, 2, 8, and 9 of each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Jan S. Moreb, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-02-28
Completion
2013-02-28

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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 NCT01680796 on ClinicalTrials.gov