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NCT01842308 · OUTCOME

Determine Maximum Tolerated Dose by the Number of Patients With a DLT Per Dose Level

Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2020-09-01

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
Up to day 30

What was measured

Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity(DLT) in at least one-third of patients. For this study, a DLT is any of the following during the first 2 cycles of treatment; Absolute neutrophil count engraftment\* delayed beyond day 21 or Platelet engraftment\* delayed beyond day 30, grade 3+ related sensory or motor neuropathy, or grade 4+ related non-neurologic or non-hematologic adverse event(excluding nausea, vomiting, and diarrhea. Reported below are the number of patients who experienced a DLT.

Analysis population: All phase 1 patients that began treatment.

Groups in this outcome

Phase 1: Dose Level 3

CONDITIONING: Patients receive 56 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 2

CONDITIONING: Patients receive 45 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 1

CONDITIONING: Patients receive 36 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 0

CONDITIONING: Patients receive 27 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: 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
Phase 1: Dose Level 36
Phase 1: Dose Level 23
Phase 1: Dose Level 13
Phase 1: Dose Level 02

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 31Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    units
    Participants
description
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity(DLT) in at least one-third of patients. For this study, a DLT is any of the following during the first 2 cycles of treatment; Absolute neutrophil count engraftment\* delayed beyond day 21 or Platelet engraftment\* delayed beyond day 30, grade 3+ related sensory or motor neuropathy, or grade 4+ related non-neurologic or non-hematologic adverse event(excluding nausea, vomiting, and diarrhea. Reported below are the number of patients who experienced a DLT.
groups
  1. description
    CONDITIONING: Patients receive 56 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
    id
    OG000
    title
    Phase 1: Dose Level 3
  2. description
    CONDITIONING: Patients receive 45 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
    id
    OG001
    title
    Phase 1: Dose Level 2
  3. description
    CONDITIONING: Patients receive 36 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
    id
    OG002
    title
    Phase 1: Dose Level 1
  4. description
    CONDITIONING: Patients receive 27 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
    id
    OG003
    title
    Phase 1: Dose Level 0
param Type
COUNT_OF_PARTICIPANTS
population Description
All phase 1 patients that began treatment.
reporting Status
POSTED
time Frame
Up to day 30
title
Determine Maximum Tolerated Dose by the Number of Patients With a DLT Per Dose Level
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice