At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 157 enrolled
Drug / intervention
Melphalan flufenamide (Melflufen) +1 moredrug
Likely dose
Not stated in 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.
A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody
In Brief
A Phase 2 clinical trial evaluating Melphalan flufenamide (Melflufen) and Dexamethasone for Multiple Myeloma. Completed, enrolled 157 participants across 20 sites in 4 countries.
Detailed Summary
This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesFrance, Italy, Spain, United States
CollaboratorsPrecision For Medicine
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionOct 2020
Study CompletionNov 2021
TodayJul 2026
First PostedNov 15, 2016
Enrollment StartDec 28, 2016
Primary CompletionOct 22, 2020
Study CompletionNov 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.6 years ago
Interventions
Melphalan flufenamide (Melflufen)drug
Dexamethasonedrug
IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.