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Dexamethasone

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Dexamethasone acetate

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Adjuvants, Immunologic

Immunologic Factors

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

ARRY-520, KSP(Eg5) inhibitor; intravenous

Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.

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

Dexamethasone, steroid; oral

Pfizer CT.gov Call Center

This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520.

The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting).

In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).

In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).

A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Pfizer

Anti-Infective Agents

Bortezomib

Proteasome Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

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

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

Bortezomib, proteasome inhibitor; intravenous or subcutaneous

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

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).

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

Array Biopharma, now a wholly owned subsidiary of Pfizer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma	NCT00821249	Multiple Myelom... Plasma Cell Leu...	ARRY-520, KSP(E... Filgrastim, gra... Dexamethasone, ...	18 Years -	Pfizer
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma	NCT00821249	Multiple Myelom... Plasma Cell Leu...	ARRY-520, KSP(E... Filgrastim, gra... Dexamethasone, ...	18 Years -	Pfizer
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma	NCT01248923	Multiple Myelom...	ARRY-520, KSP(E... Bortezomib, pro... Dexamethasone, ... Filgrastim, gra... ARRY-520, KSP(E... Bortezomib, pro... Filgrastim, gra...	18 Years -	Array BioPharma
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma	NCT01248923	Multiple Myelom...	ARRY-520, KSP(E... Bortezomib, pro... Dexamethasone, ... Filgrastim, gra... ARRY-520, KSP(E... Bortezomib, pro... Filgrastim, gra...	18 Years -	Array BioPharma

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