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NCT03417284 · OUTCOME

Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.

Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation · Source last updated 2025-05-01

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Within 30 days after the start of infusion

What was measured

Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.

Groups in this outcome

Group1_Dose 1 200mgm2

PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV

Group 1_Dose 2 225mgm2

PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV

Group 2_Dose 1 200mgm2

PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV

Group 2_Dose 225mgm2

PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group1_Dose 1 200mgm24
Group 1_Dose 2 225mgm227
Group 2_Dose 1 200mgm24
Group 2_Dose 225mgm227

Reported measurements

Grade 4 Mucositis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group1_Dose 1 200mgm20Not reportedNot reportedNot reportedNot reported
Group 1_Dose 2 225mgm20Not reportedNot reportedNot reportedNot reported
Group 2_Dose 1 200mgm20Not reportedNot reportedNot reportedNot reported
Group 2_Dose 225mgm20Not reportedNot reportedNot reportedNot reported
Grade 4 non-hematologic or non-infectious toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group1_Dose 1 200mgm20Not reportedNot reportedNot reportedNot reported
Group 1_Dose 2 225mgm20Not reportedNot reportedNot reportedNot reported
Group 2_Dose 1 200mgm20Not reportedNot reportedNot reportedNot reported
Group 2_Dose 225mgm20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Grade 4 Mucositis
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Grade 4 non-hematologic or non-infectious toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      27
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      27
    units
    Participants
description
Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
groups
  1. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    OG000
    title
    Group1_Dose 1 200mgm2
  2. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    OG001
    title
    Group 1_Dose 2 225mgm2
  3. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    OG002
    title
    Group 2_Dose 1 200mgm2
  4. description
    PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\^9/L. Autologous Hematopoietic Stem Cell Transplantation: Undergo HSCT Filgrastim-sndz: Given SC Melphalan Hydrochloride: Given IV
    id
    OG003
    title
    Group 2_Dose 225mgm2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within 30 days after the start of infusion
title
Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice