CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection +1 moredrug
Likely dose
Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00925782
NCT00925782Phase 2Completed
CompareCT.gov

AA Phase IIA Open-Label, Randomized, PK Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in MM Patients Undergoing Autologous Transplantation

Acrotech Biopharma Inc.·interventional·Posted Jun 22, 2009·Updated Dec 17, 2019

In Brief

A Phase 2 clinical trial evaluating Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection and Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free) for Multiple Myeloma. Completed, enrolled 24 participants across 1 site.

Detailed Summary

To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2009
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.0 years ago

Interventions

Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injectiondrug

Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT.

Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)drug

Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.