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NCT01729091 · OUTCOME

Number of Participants With Dose Limiting Toxicities

Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2025-05-09

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 post-transplant

What was measured

Dose limiting toxicity is defined as number of participants experienced: * grade 4 NK infusion related toxicity, * failure to engraft by D+28 or delayed engraftment, * grades 3-5 allergic reactions related to study cell infusion, * grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy or due to preparative chemotherapy and occurring within 30 days (+3 days if necessary) post-transplant, * grades 3-4 acute GVHD occurring within 45 days post-transplant, * treatment-related death within 8 weeks of the study cell infusion.

Groups in this outcome

P1_C1_5x10^6

Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV

P1_C2_1x10^7

Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV

P1_C3_5x10^7

Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV

P1_C4_1X10^8

Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV

P2_1x10^8+Elotuzumab

Patients receive elotuzumab IV over 2-5 hours on day -15 and -8, lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: 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
P1_C1_5x10^63
P1_C2_1x10^73
P1_C3_5x10^74
P1_C4_1X10^832
P2_1x10^8+Elotuzumab30

Reported measurements

grade 4 NK infusion related toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^60Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^80Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab0Not reportedNot reportedNot reportedNot reported
failure to engraft by D+28 or delayed engraftment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^60Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^81Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab0Not reportedNot reportedNot reportedNot reported
· grades 3-5 allergic reactions related to study cell infusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^60Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^80Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab0Not reportedNot reportedNot reportedNot reported
grade 3-5 organ toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^61Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^813Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab11Not reportedNot reportedNot reportedNot reported
grades 3-4 acute GVHD occurring within 45 days post-transplant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^60Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^80Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab0Not reportedNot reportedNot reportedNot reported
treatment-related death within 8 weeks of the study cell infusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
P1_C1_5x10^60Not reportedNot reportedNot reportedNot reported
P1_C2_1x10^70Not reportedNot reportedNot reportedNot reported
P1_C3_5x10^70Not reportedNot reportedNot reportedNot reported
P1_C4_1X10^80Not reportedNot reportedNot reportedNot reported
P2_1x10^8+Elotuzumab0Not 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
      5. group Id
        OG004
        value
        0
    title
    grade 4 NK infusion related toxicity
  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
        1
      5. group Id
        OG004
        value
        0
    title
    failure to engraft by D+28 or delayed engraftment
  3. 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
      5. group Id
        OG004
        value
        0
    title
    · grades 3-5 allergic reactions related to study cell infusion
  4. 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
        13
      5. group Id
        OG004
        value
        11
    title
    grade 3-5 organ toxicity
  5. 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
      5. group Id
        OG004
        value
        0
    title
    grades 3-4 acute GVHD occurring within 45 days post-transplant
  6. 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
      5. group Id
        OG004
        value
        0
    title
    treatment-related death within 8 weeks of the study cell infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      32
    5. group Id
      OG004
      value
      30
    units
    Participants
description
Dose limiting toxicity is defined as number of participants experienced: * grade 4 NK infusion related toxicity, * failure to engraft by D+28 or delayed engraftment, * grades 3-5 allergic reactions related to study cell infusion, * grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy or due to preparative chemotherapy and occurring within 30 days (+3 days if necessary) post-transplant, * grades 3-4 acute GVHD occurring within 45 days post-transplant, * treatment-related death within 8 weeks of the study cell infusion.
groups
  1. description
    Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV
    id
    OG000
    title
    P1_C1_5x10^6
  2. description
    Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV
    id
    OG001
    title
    P1_C2_1x10^7
  3. description
    Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV
    id
    OG002
    title
    P1_C3_5x10^7
  4. description
    Patients receive lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV
    id
    OG003
    title
    P1_C4_1X10^8
  5. description
    Patients receive elotuzumab IV over 2-5 hours on day -15 and -8, lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Melphalan: Given IV Natural Killer Cell Therapy: Given IV Umbilical Cord Blood-Derived Lymphocyte Therapy: Given IV
    id
    OG004
    title
    P2_1x10^8+Elotuzumab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within 30 days post-transplant
title
Number of Participants With Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice