TriangleNCT01729091 · STUDY IN CONTEXT
Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Number of participants that are alive and disease free one year post transplant
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- trial label
- Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 3
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- source section id
- NCT01729091-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose Limiting Toxicities
- endpoint definition
- 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.
- time origin
- Within 30 days post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- source section id
- NCT01729091-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)
- endpoint definition
- 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.
- time origin
- At 3 months post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0002
- source section id
- NCT01729091-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- Number of participants that are alive and disease free one year post transplant
- time origin
- Up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- arm key
- OG000
- arm label
- P1_C1_5x10^6
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- arm key
- OG001
- arm label
- P1_C2_1x10^7
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- arm key
- OG002
- arm label
- P1_C3_5x10^7
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- arm key
- OG003
- arm label
- P1_C4_1X10^8
- regimen
- 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
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0000
- arm key
- OG004
- arm label
- P2_1x10^8+Elotuzumab
- regimen
- 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
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- arm key
- OG000
- arm label
- P1_C1_5x10^6
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- arm key
- OG001
- arm label
- P1_C2_1x10^7
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- arm key
- OG002
- arm label
- P1_C3_5x10^7
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- arm key
- OG003
- arm label
- P1_C4_1X10^8
- regimen
- 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
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0001
- arm key
- OG004
- arm label
- P2_1x10^8+Elotuzumab
- regimen
- 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
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0002
- arm key
- OG000
- arm label
- P1_C1_5x10^6
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- outcome key
- om-0002
- arm key
- OG001
- arm label
- P1_C2_1x10^7
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01729091-om-0002#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- harm key
- EG000
- source section id
- NCT01729091-ae
- event group key
- EG000
- event group label
- P1_C1_5x10^6
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 12 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- harm key
- EG001
- source section id
- NCT01729091-ae
- event group key
- EG001
- event group label
- P1_C2_1x10^7
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 12 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- harm key
- EG002
- source section id
- NCT01729091-ae
- event group key
- EG002
- event group label
- P1_C3_5x10^7
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Up to 12 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- harm key
- EG003
- source section id
- NCT01729091-ae
- event group key
- EG003
- event group label
- P1_C4_1X10^8
- serious affected
- 1
- serious at risk
- 32
- other affected
- 32
- other at risk
- 32
- frequency threshold
- 0
- collection period
- Up to 12 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01729091
- harm key
- EG004
- source section id
- NCT01729091-ae
- event group key
- EG004
- event group label
- P2_1x10^8+Elotuzumab
- serious affected
- 1
- serious at risk
- 30
- other affected
- 27
- other at risk
- 30
- frequency threshold
- 0
- collection period
- Up to 12 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice