Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Leukemia

Leukemia, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Plasma Cell Leukemia

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Lenograstim

Bortezomib

Dexamethasone acetate

Proteasome Inhibitors

Filanesib

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adjuvants, Immunologic

Immunologic Factors

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

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

ARRY-520, KSP(Eg5) inhibitor; intravenous

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

Bortezomib, proteasome inhibitor; intravenous or subcutaneous

Dexamethasone, steroid; oral

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

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

Pfizer CT.gov Call Center

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	Link
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

Spots Global Cancer Trial Database for bortezomib, proteasome inhibitor; intravenous or subcutaneous