CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Carfilzomib +1 moredrug
Likely dose
Carfilzomib administered as IV bolus; specific dose not stated in eligibility or armsAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed diagnosis of multiple myeloma, non-Hodgkin's lymphoma, Waldenström's macroglobulinemia, or Hodgkin's disease
  • ✓Refractory or relapsed disease after at least 2 prior therapies
  • ✓Age ≥18 years
  • ✓ECOG performance status 0-2
Key exclusion· 13
  • ✕Transfusion dependent
  • ✕Recent steroid therapy: NHL/HL within 7 days; MM/WM within 3 weeks (except DEX expansion cohort)
  • ✕Chemotherapy, radiation, or immunotherapy within 4 weeks or inadequate recovery from prior therapy
  • ✕Prior allogeneic stem cell transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00150462
NCT00150462Phase 1Completed
CompareCT.gov

A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies

Amgen·interventional·Posted Sep 8, 2005·Updated May 2, 2017

In Brief

A Phase 1 clinical trial evaluating Carfilzomib and Dexamethasone for Waldenstrom's Macroglobulinemia and 3 related conditions. Completed, enrolled 48 participants across 5 sites.

Detailed Summary

The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartSep 1, 2005
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Carfilzomibdrug

Administered as an IV bolus dose

Dexamethasonedrug

Administered orally prior to carfilzomib