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A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

NCT01248923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-09-30

No results posted yet for this study

Summary

This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).

In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Conditions

  • Multiple Myeloma, Plasma Cell Leukemia

Interventions

DRUG

ARRY-520, KSP(Eg5) inhibitor; intravenous

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

DRUG

Bortezomib, proteasome inhibitor; intravenous or subcutaneous

Part 1: standard of care; Part 2: standard of care determined in Part 1.

DRUG

Dexamethasone, steroid; oral

Part 1: standard of care; Part 2: standard of care determined in Part 1.

DRUG

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Part 1: standard of care; Part 2: standard of care.

DRUG

ARRY-520, KSP(Eg5) inhibitor; intravenous

Part 1: multiple dose, escalating

DRUG

Bortezomib, proteasome inhibitor; intravenous or subcutaneous

Part 1: standard of care

DRUG

Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Part 1: standard of care

Sponsors & Collaborators

  • Array Biopharma, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

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
2010-12-31
Primary Completion
2016-03-31

Countries

  • United States

Study Locations

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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 NCT01248923 on ClinicalTrials.gov