Clinical Trial VICCHEM1377
A Phase 1 Study of Arry-520 and Bortezomib plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
- Protocol No. VICCHEM1377
- Open Date: 03/14/2014
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To determine the safety and the MTD of ARRY-520 when combined with bortezomib plus dexamethasone.
- Disease Sites: Multiple Myeloma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: ARRY-520; Bortezomib (BTZ); Dexamethasone; VELCADE
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01248923
- Secondary Protocol No: ARRAY-520-111
Patients are being asked to take part in this research study because their cancer, either multiple myeloma or plasma cell leukemia, has recurred after, or progressed during, treatment with standard therapy. This study is being done to: - To collect information about the safety of an investigational drug called ARRY-520, given in two different schedules, in combination with bortezomib (also called Velcade) with and without dexamethasone, to see what effects it has on patients with Multiple Myeloma or Plasma Cell Leukemia. - Find the highest dose of ARRY-520, given in two different schedules, in combination with bortezomib with and without dexamethasone, which can be given to patients without causing unacceptable side effects. - To see how ARRY-520 together with bortezomib with and without dexamethasone affects the body and cancer, - To learn how the body processes ARRY-520 and bortezomib The study will take place in five parts because two different schedules for dosing of ARRY-520 are to be tested (called Schedule 1 and Schedule 2). The first three parts of the study will give ARRY-520 on Schedule 1 (four times during a treatment cycle); the last two parts of the study will give ARRY-520 on Schedule 2 (two times during a treatment cycle).
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
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.