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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/23/2016
Start Date:December 2010

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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).


Key Inclusion Criteria (Part 1 and Part 2):

- Confirmed relapsed or refractory MM (measurable disease) or PCL.

- Prior treatment regimens for Part 1: Patients should have received at least 2 prior
treatment regimens. Prior treatment must have included at least one full cycle of a
proteasome inhibitor (e.g., bortezomib or carfilzomib) and at least one full cycle of
an IMiD (e.g., thalidomide, lenalidomide or pomalidomide).

- Prior treatment regimens for Part 2: Patients should have received 1 to 3 prior
treatment regimens. Prior treatment could have included bortezomib only if the
disease was not refractory to treatment with bortezomib (refractory defined as
documented progression on therapy or within 60 days of completing treatment with
bortezomib).

- The disease should have progressed per IMWG criteria during or after the last prior
treatment regimen.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Adequate hematology laboratory values without transfusion support and without
hematological growth factor support within 2 weeks of screening.

- Adequate liver and renal function.

- Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

- Primary amyloidosis.

- Peripheral neuropathy ≥ Grade 2 or neuropathy with pain, regardless of grade.

- Concomitant malignancies or previous malignancies with less than a 3-year disease
free interval at the time of enrollment (patients with adequately resected basal or
squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low
grade prostate cancer may enroll irrespective of the time of diagnosis).

- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to
first dose of study drug.

- Treatment with an investigational medicinal product or device within 28 days prior to
first dose of study drug.

- Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of
study drug.

- Radiotherapy within 21 days prior to first dose of study drug (if the radiation
portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled
irrespective of the end date of radiotherapy).

- Major surgery within 14 days and minor surgery within 7 days prior to first dose of
study drug.

- Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days prior to
first dose of study drug.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B
and/or active hepatitis C.

- Additional criteria exist.
We found this trial at
13
sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, GA
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Charleston, South Carolina 29403
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Charleston, SC
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Dallas, TX
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Detroit, Michigan 48201
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Duarte, California 91010
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Duarte, CA
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Germantown, Tennessee 38138
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Germantown, TN
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Huntsville, Alabama 35805
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Huntsville, AL
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New York, New York 10016
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New York, NY
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Rockville, Maryland 20850
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Rockville, MD
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Tucson, Arizona 85712
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Tucson, AZ
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