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Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma, Plasma Cell Leukemia

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Trial Information

Inclusion Criteria

Key Inclusion Criteria (Part 3):

- Patients should have received at least two prior treatment regimens.

- Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to
treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to
treatment with bortezomib/lenalidomide/dexamethasone), defined as documented
progressive disease on therapy or within 60 days of completing treatment with these

- Previously received adequate alkylator therapy.

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

- Adequate hematology laboratory values without transfusion support within 2 weeks of

- Adequate liver and renal function.

- Additional criteria exist.

Key Exclusion Criteria (Part 3):

- Primary amyloidosis.

- 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.

- 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).

- Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks 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:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.

Outcome Time Frame:

Part 1

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

May 2013

Related Keywords:

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



MD Anderson Cancer Center Houston, Texas  77030-4096
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Karmanos Cancer Institute Detroit, Michigan  48201
Emory University, Winship Cancer Institute Atlanta, Georgia  30322