A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Key Inclusion Criteria:
Multiple myeloma that is primary refractory or relapsed and refractory after at least 2 lines of standard for multiple myeloma including:
- ≥ 2 consecutive cycles of both bortezomib and lenalidomide or thalidomide (alone or in combination)
- In the dose-expansion and Phase 3 portions of the study only: In addition to the above, treatment with adequate alkylator therapy, defined as:
i. High-dose melphalan or other alkylating agent as conditioning for autologous or allogeneic stem cell transplant (SCT), or ii. ≥ 6 cycles of induction therapy, or iii. Progressive disease after ≥ 2 cycles
- Disease progression on or within 60 days of completion of the last therapy
Measurable disease as indicated by 1 or more of the following:
- Serum M-protein ≥ 500 mg/dL
- Urine M-protein ≥ 200 mg/24 h
- For patients without measurable serum or urine M protein, serum free light chain (SFLC): Involved free light chain (FLC) concentration ≥ 10 mg/dL provided SFLC ratio is abnormal
- Males and females ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Key Exclusion Criteria:
- Systemic chemotherapy with approved or investigational anticancer therapeutics, intended to treat underlying malignancy, within 3 weeks before the first dose or 6 weeks for antibody therapy
- Dexamethasone at cumulative doses greater than 160 mg or equivalent within 21 days prior to the first dose of study treatment is not allowed. Use of topical or inhaled steroids is acceptable.
- Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks before first dose.
- Plasmapheresis is not permitted at any time during the Screening period or while the subject is receiving study treatment. If a subject has started Screening procedures requiring plasmapheresis, or is anticipated to require plasmapheresis during or after the Screen
- Autologous SCT within 8 weeks or allogeneic SCT within 16 weeks prior to initiation of study treatment. Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (as defined in Filipovich 2005).
- Known hypersensitivity to any immunomodulatory drugs (IMiDs), including Grade 4 rash
- Prior treatment of any duration with pomalidomide
- Known hypersensitivity or intolerance to dexamethasone
- Prior exposure to oprozomib
- Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose.
Sites / Locations
- California Cancer Associates For Research and Exellence, cCare
- James R. Berenson, MD, Inc.
- Innovative Clinical Research Institute
- Rocky Mountain Cancer Centers
- Oncology Hematology West PC, dba Nebraska Cancer Specialists
- Weill Cornell Medical College-New York Presbyterian Hospital
- Levine Cancer Institute
- Duke University Medical Center
- Willamette Valley Cancer Institute and Research Center
- Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
- University of Pennsylvania
- Tennessee Oncology, PLLC / Sarah Cannon Research Institute
- The University of Texas M.D. Anderson Cancer Center
- Cancer Care Centers of South Texas-HOAST
- Virginia Cancer Specialists, PC
- Virginia Oncology Associates
- Yakima Valley Memorial Hospital/North Star Lodge
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.