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Corticosteroid
Dexamethasone for Multiple Myeloma (INTREPID-1 Trial)
Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
INTREPID-1 Trial Summary
This trial is testing two new treatments for patients with a certain type of blood cancer who have already tried other treatments.
Eligible Conditions
- Multiple Myeloma
INTREPID-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dexamethasone
Incidence of treatment-emergent adverse events
Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment
+1 moreSecondary outcome measures
Area under the concentration-time curve
Best overall response
Duration of response
+4 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
INTREPID-1 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2 Arm 2Experimental Treatment3 Interventions
Oprozomib (Gastro-retentive) plus pomalidomide and dexamethasone
Group II: Part 2 Arm 1Experimental Treatment3 Interventions
Oprozomib (Immediate release) plus pomalidomide and dexamethasone
Group III: Part 1 Arm 2Experimental Treatment2 Interventions
Oprozomib (Gastro-retentive) plus dexamethasone
Group IV: Part 1 Arm 1Experimental Treatment2 Interventions
Oprozomib (Immediate Release) plus dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immediate Release (IR) Formulation
2017
Completed Phase 1
~70
Gastro-Retentive (GR) Formulation
2017
Completed Phase 1
~70
Dexamethasone
2007
Completed Phase 4
~2590
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,627 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,679 Patients Enrolled for Multiple Myeloma
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,070 Total Patients Enrolled
44 Trials studying Multiple Myeloma
11,284 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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