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Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Plasma Cell Leukemia

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Trial Information

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.

Outcome Time Frame:

Until MTD is reached

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-520-111

NCT ID:

NCT01248923

Start Date:

December 2010

Completion Date:

January 2014

Related Keywords:

  • Multiple Myeloma, Plasma Cell Leukemia
  • relapsed multiple myeloma
  • plasma cell dyscrasia
  • plasmacytoma
  • kinesin spindle protein
  • anti-mitotic
  • Leukemia
  • Leukemia, Plasma Cell
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mount Sinai Medical CenterNew York, New York  10029
City of HopeDuarte, California  91010
Karmanos Cancer InstituteDetroit, Michigan  48201
Emory University, Winship Cancer InstituteAtlanta, Georgia  30322
Baylor Charles A. Sammons Cancer Center at DallasDallas, Texas  75246