At a glance
ClinicalIndex Comparison RecordPhase 2Active· 52 enrolled
Drug / intervention
lenalidomide +1 moredrug
Likely dose
melphalan 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.
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
In Brief
A Phase 2 clinical trial evaluating lenalidomide and melphalan for Multiple Myeloma. Active but no longer recruiting, targeting 52 participants across 1 site.
Detailed Summary
A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT). B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsCelgene
Timeline
Phase 2Active
201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2010
Enrollment StartAug 2010
Primary CompletionOct 2021
TodayJul 2026
Study CompletionDec 2026
First PostedJan 22, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2021
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 11.2 yearsPosted 16.4 years ago
Interventions
lenalidomidedrug
daily dose dependent on dose-escalation schedule
melphalandrug
100 mg/m2 given Days -2 and -1