NCT01729091 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 12 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	0 / 3	3 / 3	2 / 3
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	0 / 3	3 / 3	2 / 3
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	0 / 4	4 / 4	2 / 4
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	1 / 32	32 / 32	11 / 32
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	1 / 30	27 / 30	3 / 30

Group identifiers: EG000: P1_C1_5x10^6 · EG001: P1_C2_1x10^7 · EG002: P1_C3_5x10^7 · EG003: P1_C4_1X10^8 · EG004: P2_1x10^8+Elotuzumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Low platelet
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Primary graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Viral

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
5
num At Risk
30
num Events
5
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
6
num At Risk
32
num Events
6
group Id
EG004
num Affected
6
num At Risk
30
num Events
6
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
6
num At Risk
30
num Events
6
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
8
num At Risk
32
num Events
8
group Id
EG004
num Affected
7
num At Risk
30
num Events
7
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
2
num At Risk
30
num Events
2
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
5
num At Risk
30
num Events
5
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Cystitis noninfective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
4
num Events
3
group Id
EG003
num Affected
27
num At Risk
32
num Events
27
group Id
EG004
num Affected
25
num At Risk
30
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Dry eye

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
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
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
P1_C1_5x10^6
deaths Num Affected
2
deaths Num At Risk
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
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
P1_C2_1x10^7
deaths Num Affected
2
deaths Num At Risk
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
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
P1_C3_5x10^7
deaths Num Affected
11
deaths Num At Risk
32
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
EG003
other Num Affected
32
other Num At Risk
32
serious Num Affected
1
serious Num At Risk
32
title
P1_C4_1X10^8
deaths Num Affected
3
deaths Num At Risk
30
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
EG004
other Num Affected
27
other Num At Risk
30
serious Num Affected
1
serious Num At Risk
30
title
P2_1x10^8+Elotuzumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
5
num At Risk
30
num Events
5
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
6
num At Risk
32
num Events
6
group Id
EG004
num Affected
6
num At Risk
30
num Events
6
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
6
num At Risk
30
num Events
6
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
8
num At Risk
32
num Events
8
group Id
EG004
num Affected
7
num At Risk
30
num Events
7
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
2
num At Risk
30
num Events
2
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
5
num At Risk
30
num Events
5
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Cystitis noninfective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
4
num Events
3
group Id
EG003
num Affected
27
num At Risk
32
num Events
27
group Id
EG004
num Affected
25
num At Risk
30
num Events
25
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Dry eye

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Low platelet
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
0
num At Risk
30
num Events
0
term
Primary graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
group Id
EG004
num Affected
1
num At Risk
30
num Events
1
term
Viral

time Frame

Up to 12 months

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

Preserved source evidence · Not medical advice