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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02939183
Registration number
NCT02939183
Ethics application status
Date submitted
18/10/2016
Date registered
19/10/2016
Date last updated
8/12/2022
Titles & IDs
Public title
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
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Scientific title
(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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20160104
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Universal Trial Number (UTN)
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Trial acronym
INTREPID-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Immediate Release (IR) Formulation
Treatment: Drugs - Gastro-Retentive (GR) Formulation
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Pomalidomide
Experimental: Part 1 Arm 1 - Oprozomib (Immediate Release) plus dexamethasone
Experimental: Part 1 Arm 2 - Oprozomib (Gastro-retentive) plus dexamethasone
Experimental: Part 2 Arm 1 - Oprozomib (Immediate release) plus pomalidomide and dexamethasone
Experimental: Part 2 Arm 2 - Oprozomib (Gastro-retentive) plus pomalidomide and dexamethasone
Treatment: Drugs: Immediate Release (IR) Formulation
Immediate Release (IR) Formulation
Treatment: Drugs: Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
Treatment: Drugs: Dexamethasone
Dexamethasone
Treatment: Drugs: Pomalidomide
Pomalidomide
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone
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Assessment method [1]
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Timepoint [1]
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The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
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Primary outcome [2]
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Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment
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Assessment method [2]
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Timepoint [2]
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Data collected up to 2 months from the date of last subject enrollment.
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Primary outcome [3]
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Incidence of treatment-emergent adverse events
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Assessment method [3]
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Timepoint [3]
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Data collected up to 2 months from the date of last subject enrollment.
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Primary outcome [4]
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Number of patients with changes in laboratory test results
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Assessment method [4]
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Timepoint [4]
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The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
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Secondary outcome [1]
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Maximum observed concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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At the highest concentration of drug in the blood.
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Secondary outcome [2]
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Time to Cmax (tmax)
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Assessment method [2]
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Timepoint [2]
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time to achieve Cmax.
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Secondary outcome [3]
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Area under the concentration-time curve
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Assessment method [3]
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Timepoint [3]
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time 0 to the time of last quantifiable concentration (AUClast)
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Secondary outcome [4]
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Overall response
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Assessment method [4]
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Timepoint [4]
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All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
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Secondary outcome [5]
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Best overall response
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Assessment method [5]
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Timepoint [5]
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All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
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Secondary outcome [6]
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Progression free survival
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Assessment method [6]
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Timepoint [6]
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4 months
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Secondary outcome [7]
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Duration of response
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Assessment method [7]
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Timepoint [7]
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4 months
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Eligibility
Key inclusion criteria
Inclusion criteria
- Subject must have a pathologically documented, definitively diagnosed, multiple
myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy
for multiple myeloma. Prior therapeutic treatment or regimens must include a
proteasome inhibitor and lenalidomide.
- Subject must be willing and able to undergo bone marrow aspirate per protocol (with or
without bone marrow biopsy per institutional guidelines).
- Measurable disease (assessed within 28 days prior to day 1)
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Other Inclusion Criteria May Apply
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study, or less
than 28 days or 5 half-lives whichever is shorter since ending treatment on another
investigational device or drug study(s).
- Previously received an allogeneic stem cell transplant and the occurrence of one or
more of the following: received the transplant within 6 months prior to study day
1;received immunosuppressive therapy within the last 3 months prior to study day
1;having signs or symptoms of acute or chronic graft-versus-host disease.
- Autologous stem cell transplant < 90 days prior to study day 1.
- Multiple myeloma with IgM subtype.
- POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).
- Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
- Waldenstrom's macroglobulinemia.
- Other Exclusion Criteria May Apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/10/2022
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Sample size
Target
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Accrual to date
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Final
61
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Research Site - Clayton
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Recruitment hospital [2]
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Research Site - Murdoch
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Recruitment hospital [3]
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Research Site - Perth
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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6150 - Murdoch
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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California
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Florida
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Missouri
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Gent
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Castilla León
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Spain
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Navarra
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in
patients with relapsed refractory multiple myeloma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02939183
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02939183
Download to PDF