NCT01729091 · OUTCOME

Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)

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: At 3 months post-transplant

What was measured

Complete response (CR) (all of the following): 1. Negative immunofixation in serum and urine. 2. \< 5% plasma cells in the bone marrow. 3. Disappearance of any soft tissue plasmacytomas. Very good partial response (VGPR) (one of the following): 1. Serum and urine M protein detectable by immunofixation but not by electrophoresis. 2. 90% or greater reduction in serum M protein plus urine M protein level \<100 mg per 4h.

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

P1_C3_5x10^7

P1_C4_1X10^8

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

Group	Source count
P1_C1_5x10^6	3
P1_C2_1x10^7	3
P1_C3_5x10^7	4
P1_C4_1X10^8	32
P2_1x10^8+Elotuzumab	30

Reported measurements

VGPR

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
P1_C1_5x10^6	1	Not reported	Not reported	Not reported	Not reported
P1_C2_1x10^7	0	Not reported	Not reported	Not reported	Not reported
P1_C3_5x10^7	1	Not reported	Not reported	Not reported	Not reported
P1_C4_1X10^8	4	Not reported	Not reported	Not reported	Not reported
P2_1x10^8+Elotuzumab	5	Not reported	Not reported	Not reported	Not reported

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
P1_C1_5x10^6	1	Not reported	Not reported	Not reported	Not reported
P1_C2_1x10^7	3	Not reported	Not reported	Not reported	Not reported
P1_C3_5x10^7	2	Not reported	Not reported	Not reported	Not reported
P1_C4_1X10^8	17	Not reported	Not reported	Not reported	Not reported
P2_1x10^8+Elotuzumab	22	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
5
title
VGPR
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
17
group Id
OG004
value
22
title
CR

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
32
group Id
OG004
value
30
units
Participants

description

groups

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
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
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
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
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

At 3 months post-transplant

title

Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice