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Proteasome Inhibitor

Carfilzomib and Dexamethasone for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Joshua Richter, M.D
Research Sponsored by Oncotherapeutics
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 monthly, up to 24 months
Awards & highlights

Study Summary

This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Establish maximum tolerated dose (MTD)
Secondary outcome measures
Establish efficacy as assessed by the overall response rate
Other outcome measures
Relationship of 60-minute infusion of carflizomib with pharmacodynamic markers

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carfilzomib and DexamethasoneExperimental Treatment1 Intervention
Phase 1: Carfilzomib will be administered at an escalating dose with dexamethasone administered at 8mg. Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: Carfilzomib and dexamethasone will be administered in the same fashion as the previous treatment cycles, but only on days 1, 2, 15, and 16.

Find a Location

Who is running the clinical trial?

OncotherapeuticsLead Sponsor
22 Previous Clinical Trials
905 Total Patients Enrolled
21 Trials studying Multiple Myeloma
882 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,378 Previous Clinical Trials
1,379,364 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,702 Patients Enrolled for Multiple Myeloma
Joshua Richter, M.DPrincipal InvestigatorJohn Theurer Cancer Center at Hackensack University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma
2013. "Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01792102.
All > Myeloma
~3 spots leftby May 2025
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