Trial Outcomes & Findings for Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma (NCT NCT01729091)
NCT ID: NCT01729091
Last Updated: 2025-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Within 30 days post-transplant
Results posted on
2025-05-09
Participant Flow
All participants were registered in MD Anderson Cancer Center.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
32
|
30
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
P1_C1_5x10^6
n=3 Participants
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
n=3 Participants
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
n=4 Participants
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
n=32 Participants
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
n=30 Participants
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
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
32 participants
n=4 Participants
|
30 participants
n=21 Participants
|
72 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Within 30 days post-transplantDose 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.
Outcome measures
| Measure |
P1_C4_1X10^8
n=32 Participants
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
n=30 Participants
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
|
P1_C1_5x10^6
n=3 Participants
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
n=3 Participants
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
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
grade 4 NK infusion related toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicities
failure to engraft by D+28 or delayed engraftment
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicities
· grades 3-5 allergic reactions related to study cell infusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicities
grade 3-5 organ toxicity
|
13 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicities
grades 3-4 acute GVHD occurring within 45 days post-transplant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose Limiting Toxicities
treatment-related death within 8 weeks of the study cell infusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At 3 months post-transplantComplete 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.
Outcome measures
| Measure |
P1_C4_1X10^8
n=32 Participants
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
n=30 Participants
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
|
P1_C1_5x10^6
n=3 Participants
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
n=3 Participants
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
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)
VGPR
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)
CR
|
17 Participants
|
22 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsNumber of participants that are alive and disease free one year post transplant
Outcome measures
| Measure |
P1_C4_1X10^8
n=32 Participants
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
n=30 Participants
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
|
P1_C1_5x10^6
n=3 Participants
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
n=3 Participants
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
n=4 Participants
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
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
28 Participants
|
28 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
P1_C1_5x10^6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
P1_C2_1x10^7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
P1_C3_5x10^7
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
P1_C4_1X10^8
Serious events: 1 serious events
Other events: 32 other events
Deaths: 11 deaths
P2_1x10^8+Elotuzumab
Serious events: 1 serious events
Other events: 27 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
P1_C1_5x10^6
n=3 participants at risk
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
n=3 participants at risk
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
n=4 participants at risk
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
n=32 participants at risk
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
n=30 participants at risk
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
|
|---|---|---|---|---|---|
|
Investigations
Low platelet
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Blood and lymphatic system disorders
Primary graft failure
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Infections and infestations
Viral
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
Other adverse events
| Measure |
P1_C1_5x10^6
n=3 participants at risk
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
n=3 participants at risk
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
n=4 participants at risk
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
n=32 participants at risk
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
n=30 participants at risk
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
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Investigations
ALK increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
16.7%
5/30 • Number of events 5 • Up to 12 months
|
|
Investigations
ALT increased
|
0.00%
0/3 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
18.8%
6/32 • Number of events 6 • Up to 12 months
|
20.0%
6/30 • Number of events 6 • Up to 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Investigations
AST increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
20.0%
6/30 • Number of events 6 • Up to 12 months
|
|
Infections and infestations
Bacterial
|
0.00%
0/3 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
50.0%
2/4 • Number of events 2 • Up to 12 months
|
25.0%
8/32 • Number of events 8 • Up to 12 months
|
23.3%
7/30 • Number of events 7 • Up to 12 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
6.7%
2/30 • Number of events 2 • Up to 12 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
16.7%
5/30 • Number of events 5 • Up to 12 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 3 • Up to 12 months
|
100.0%
3/3 • Number of events 3 • Up to 12 months
|
75.0%
3/4 • Number of events 3 • Up to 12 months
|
84.4%
27/32 • Number of events 27 • Up to 12 months
|
83.3%
25/30 • Number of events 25 • Up to 12 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
6.2%
2/32 • Number of events 2 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
6.7%
2/30 • Number of events 2 • Up to 12 months
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
13.3%
4/30 • Number of events 4 • Up to 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
50.0%
2/4 • Number of events 2 • Up to 12 months
|
43.8%
14/32 • Number of events 14 • Up to 12 months
|
53.3%
16/30 • Number of events 16 • Up to 12 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
12.5%
4/32 • Number of events 4 • Up to 12 months
|
26.7%
8/30 • Number of events 8 • Up to 12 months
|
|
General disorders
Fluid overload
|
0.00%
0/3 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
25.0%
1/4 • Number of events 1 • Up to 12 months
|
18.8%
6/32 • Number of events 6 • Up to 12 months
|
46.7%
14/30 • Number of events 14 • Up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
6.2%
2/32 • Number of events 2 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
13.3%
4/30 • Number of events 4 • Up to 12 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
16.7%
5/30 • Number of events 5 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
6.7%
2/30 • Number of events 2 • Up to 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
13.3%
4/30 • Number of events 4 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Up to 12 months
|
100.0%
3/3 • Number of events 3 • Up to 12 months
|
100.0%
4/4 • Number of events 4 • Up to 12 months
|
100.0%
32/32 • Number of events 32 • Up to 12 months
|
90.0%
27/30 • Number of events 27 • Up to 12 months
|
|
Gastrointestinal disorders
Oral mucositis
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
25.0%
1/4 • Number of events 1 • Up to 12 months
|
59.4%
19/32 • Number of events 19 • Up to 12 months
|
46.7%
14/30 • Number of events 14 • Up to 12 months
|
|
Nervous system disorders
Peripheral neuropathy
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
6.7%
2/30 • Number of events 2 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
9.4%
3/32 • Number of events 3 • Up to 12 months
|
6.7%
2/30 • Number of events 2 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
25.0%
1/4 • Number of events 1 • Up to 12 months
|
18.8%
6/32 • Number of events 6 • Up to 12 months
|
16.7%
5/30 • Number of events 5 • Up to 12 months
|
|
Investigations
T bilirubin increased
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
25.0%
1/4 • Number of events 1 • Up to 12 months
|
15.6%
5/32 • Number of events 5 • Up to 12 months
|
10.0%
3/30 • Number of events 3 • Up to 12 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/32 • Up to 12 months
|
3.3%
1/30 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
3.1%
1/32 • Number of events 1 • Up to 12 months
|
0.00%
0/30 • Up to 12 months
|
|
Infections and infestations
Viral
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
100.0%
4/4 • Number of events 4 • Up to 12 months
|
15.6%
5/32 • Number of events 5 • Up to 12 months
|
13.3%
4/30 • Number of events 4 • Up to 12 months
|
Additional Information
Samer Srour, MD / Stem Cell Transplantation
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place