A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
NCT ID: NCT01999335
Last Updated: 2021-04-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
33 participants
INTERVENTIONAL
2014-07-30
2019-04-25
Brief Summary
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The purpose of the Phase 3 part of the study is to compare the efficacy for adults with primary refractory or relapsed and refractory multiple myeloma who are randomized to either oprozomib or placebo in combination with pomalidomide and dexamethasone.
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Detailed Description
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The Phase 1 dose-escalation portion of the study followed a standard 3 + 3 dose-escalation design. For each of the 2 schedules, groups of 3 to 6 patients were enrolled. The starting doses of oprozomib were 150 and 210 mg in the 5/14 and 2/7 schedules, respectively. The starting dose of pomalidomide was 4 mg in both schedules. As long as \< 33% of patients experienced a dose-limiting toxicity (DLT) in a given cohort, the dose of oprozomib was escalated in 30-mg increments for successive cohorts.
Once the recommended dose and schedule for the expansion phase had been selected, additional participants were enrolled in the dose expansion portion of part 1 to continue the evaluation of the safety and efficacy of the regimen and determine the recommended phase 3 dose. Enrollment was halted during the dose expansion phase and part 2 was not conducted.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
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.
Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
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.
Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
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.
Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
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.
Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
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.
Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Interventions
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Oprozomib
Extended release (ER) tablets administered orally
Pomalidomide
Capsules for oral administration
Dexamethasone
Tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. ≥ 2 consecutive cycles of both bortezomib and lenalidomide or thalidomide (alone or in combination)
2. 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
2. Disease progression on or within 60 days of completion of the last therapy
3. Measurable disease as indicated by 1 or more of the following:
1. Serum M-protein ≥ 500 mg/dL
2. Urine M-protein ≥ 200 mg/24 h
3. 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
4. Males and females ≥ 18 years old
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Exclusion Criteria
2. 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.
3. Radiation therapy within 3 weeks before first dose. Radioimmunotherapy within 8 weeks before first dose.
4. 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
5. 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).
6. Known hypersensitivity to any immunomodulatory drugs (IMiDs), including Grade 4 rash
7. Prior treatment of any duration with pomalidomide
8. Known hypersensitivity or intolerance to dexamethasone
9. Prior exposure to oprozomib
10. 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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California Cancer Associates For Research and Exellence, cCare
Encinitas, California, United States
James R. Berenson, MD, Inc.
West Hollywood, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Oncology Hematology West PC, dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC / Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas-HOAST
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20130411
Identifier Type: OTHER
Identifier Source: secondary_id
OPZ007
Identifier Type: -
Identifier Source: org_study_id
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