Participant flow

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide · Source last updated 2024-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets

   id

   FG000

   title

   Arm A: Melflufen+Dexamethasone

2. description

   Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets

   id

   FG001

   title

   Arm B: Pomalidomide+Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         3

      type

      Randomized But Not Treated

   2. reasons

      1. group Id

         FG000

         num Subjects

         130

      2. group Id

         FG001

         num Subjects

         170

      type

      Progressive Disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         40

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      type

      Lack of Efficacy

   5. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         9

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         11

      type

      Study Terminated by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         246

      2. group Id

         FG001

         num Subjects

         249

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Patients were to receive treatment until there was documented disease progression, unacceptable toxicity, or the patient/treating physician determined it was not in the patient's best interest to continue. The study Sponsor terminated the study before all patients reached one of these endpoints. Shown here are the reasons for study treatment discontinuation.

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         246

      2. group Id

         FG001

         num Subjects

         249

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

246 patients were randomized to treatment Arm A, 249 patients to treatment Arm B (FAS). Of the 495 randomized patients, 228 patients in Arm A received treatment and 246 patients in Arm B received treatment (SAF). The protocol had pre-defined treatment criteria for specific laboratory values, and if the patient's values deteriorated between screening and C1D1, treatment could not be initiated. In total, 664 patients were screened, 495 randomized, 474 treated, 21 randomized but not treated.

recruitment Details

The recruitment was performed from specialized clinics' own patient pool at 115 different treatment sites in the US, Europe and Asia (20 different countries). The first patient was recruited in 12-Jun-2017 and the last patient 25-Aug-2020.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice