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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01096 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RV-MM-PI-0691 | |||
| NCI-2014-00541 | |||
| 2011-0379 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PRIMARY OBJECTIVES:
I. To find the maximum tolerated dose (MTD) of umbilical cord blood (UCB)-derived natural killer (NK) cells.
II. To determine efficacy by the percent of patients achieving very good partial remission (VGPR) + complete remission (CR) at 3 months post-transplant.
III. To assess the minimal residual disease rate 100 days post-transplant in high-risk patients.
SECONDARY OBJECTIVE:
I. To quantify duration of infused allogeneic donor UCB-derived NK cells in the recipient.
OUTLINE: This is a dose-escalation study of UCB-derived NK cells.
Patients receive elotuzumab intravenously (IV) over 2-5 hours on day -15 and -8, lenalidomide orally (PO) once daily (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.
After completion of study treatment, patients are followed up at 30, 60 and 100 days and 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy, UCB-derived NK cells, transplant) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | Undergo autologous stem cell transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities | Dose limiting toxicity is defined as number of participants experienced:
| Within 30 days post-transplant |
| Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR) | Complete response (CR) (all of the following):
Very good partial response (VGPR) (one of the following):
| At 3 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Number of participants that are alive and disease free one year post transplant | Up to 12 months |
Not provided
Inclusion Criteria:
Patients with high risk multiple myeloma who are transplant candidates, in partial response (PR) or better; high risk will be defined as patients with any of the following:
Patients with plasma cell leukemia who are transplant candidates
Performance score of at least 70% by Karnofsky or 0 to 2 Eastern Cooperative Oncology Group (ECOG)
Left ventricular ejection fraction greater than 40%
Pulmonary function test (PFT) demonstrating a diffusion capacity of least 40% predicted
Estimated serum creatinine clearance >= 60 ml/min (using the Cockcroft-Gault formula and/or serum creatinine =< 1.6 mg/dL
Serum glutamate pyruvate transaminase (SGPT) less than 3 x upper limit of normal
Total bilirubin less than 2 x upper limit of normal
All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS program
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy
Patients must have a cord blood (CB) unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
Patient or legally authorized representative able to sign informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samer S Srour | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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All participants were registered in MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2020 |
Not provided
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| Elotuzumab | Biological | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Lenalidomide | Drug | Given PO |
|
|
| Melphalan | Drug | Given IV |
|
|
| Natural Killer Cell Therapy | Biological | Given IV |
|
| Umbilical Cord Blood-Derived Lymphocyte Therapy | Biological | Given IV |
|
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities | Dose limiting toxicity is defined as number of participants experienced:
| Posted | Count of Participants | Participants | Within 30 days post-transplant |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR) | Complete response (CR) (all of the following):
Very good partial response (VGPR) (one of the following):
| Posted | Count of Participants | Participants | At 3 months post-transplant |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Number of participants that are alive and disease free one year post transplant | Posted | Count of Participants | Participants | Up to 12 months |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 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 | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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 | 2 | 4 | 0 | 4 | 4 | 4 |
| EG003 | 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 | 11 | 32 | 1 | 32 | 32 | 32 |
| EG004 | 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 | 3 | 30 | 1 | 30 | 27 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low platelet | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Primary graft failure | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Engraftment syndrome | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid overload | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| T bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samer Srour, MD / Stem Cell Transplantation | The University of Texas MD Anderson Cancer Center | 713-794-4354 | SSrour@mdanderson.org |
| Feb 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007952 | Leukemia, Plasma Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C546027 | elotuzumab |
| D000077269 | Lenalidomide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| failure to engraft by D+28 or delayed engraftment |
|
| · grades 3-5 allergic reactions related to study cell infusion |
|
| grade 3-5 organ toxicity |
|
| grades 3-4 acute GVHD occurring within 45 days post-transplant |
|
| treatment-related death within 8 weeks of the study cell infusion |
|
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
|
|
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
| OG003 | 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 |
| OG004 | 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 |
|
|