| Primary | Efficacy of BCMA CAR-T Cell Therapy | Achieving a complete response or better (CR or sCR) as assessed by the 6-month time point after BCMA CAR T-cell therapy in MM patients with suboptimal disease responses after an autologous HCT and lenalidomide maintenance. | Patients who received BCMA CAR T-Cell Therapy | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Acheived CR/sCR by 6 Months post Infusion | | | Did Not Acheive CR/sCR by 6 Months post Infusion | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | One-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%. | <0.0001 | p-value is calculated using Fisher's exact test and is a one-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%. | Proportion of Patients Achieving CR/sCR | 65.8 | | | 2-Sided | 90 | 51.2 | 78.4 | | | | | Superiority | | |
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| Secondary | Cumulative Incidence of Disease Progression | Diseases will be assessed by response categories based on the International Myeloma Working Group: Stringent Complete Response (sCR), Complete Remission (CR), Very Good Partial Remission (VGPR), Partial Remission (PR), Minimal Response (MR), Stable Disease (SD). | Participants who received an infusion | Posted | | Number | 90% Confidence Interval | Percent probability | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Proportion of Patients Achieving an Upgrade in Response Based on Their Best Disease Response | Proportion of patients achieving upgrade in response following enrollment (SD to MR or greater, MR to PR or greater, or PR to VGPR or greater) and Conversion to MRD negativity. MRD will be assessed by multi-color flow at 10-5 level | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Number of Participants With Non Relapse Mortality | Non-Relapse Mortality (NRM) is defined as death occurring in a patient from causes other than disease relapse or progression. Disease progression is the competing event for NRM. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Kaplan-Meier of Progression Free Survival | Defined as progression of disease or death from any cause. Surviving patients without disease progression will be censored at the date of last contact. | Participants who received an infusion | Posted | | Number | 90% Confidence Interval | Percent probability | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Incidence of Cytokine Release Syndrome (CRS) | Overall incidence of CRS of any grade and grade 3 or 4 CRS post CAR T-cell infusion will be reported on all patients. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | Day 4, Day 7, Day 10, Day 14, and Day 21 post-infusion | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Incidence of Prolonged Cytopenias | Overall incidence of prolonged cytopenias will be reported. Prolonged cytopenia is defined as failure to achieve ANC greater than 500/mm3 or platelet count greater than 20,000/mm3(with or without support) by 30 days post CAR T-cell infusion. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Secondary | Incidence of Neurotoxicity | Overall incidence of CAR T-cell related neurotoxicity per the ASBMT immune effector cell associated neurotoxicity syndrome (ICANS) Consensus Grading. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 1: Incidence of Toxicities Greater Than or Equal to Grade 3 Per the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | All Grade 3 or higher toxicities will be tabulated. The proportion of patients experiencing cytokine release syndrome CRS will be reported including overall and grades 3-4 based on the ASTCT grading | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: Incidence of Infections Per Protocol-specific Manual of Procedures (MOP) | incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 3: Incidence of Re-initiation of Lenalidomide Maintenance | The feasibility of resuming maintenance following enrollment by 180 days after CAR T-cell infusion will be described. The proportion of patients initiating maintenance at 180 days following bb2121 infusion will be reported. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: Number of Participants Who Did Not Die (Overall Survival) | The event is death from any cause. The time to this event is the time from initial enrollment to death, loss to follow-up, or the end of the study, whichever comes first. | Participants who received an infusion | Posted | | Count of Participants | | Participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: Summary Statistics of CAR T-cell Expansion | Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. | Participants who received an infusion | Posted | | Median | Standard Deviation | CAR T-cells (copies/mcg DNA) | | pre-LD chemo, day 4, 7, 14, 21, 30, 60, 90, 180, 270, 365 | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: Peak CAR T-cell Expansion | Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Peak CAR T-cell expansion will be compared between subjects who are and are not in CR at 6 months. | Participants who received an infusion | Posted | | Median | Standard Deviation | copies/mcg DNA | | 6 months | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: CAR T-cell Persistence Area Under the Curve Over the First 6 Months Post CAR T-cell Infusion | Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Persistence will be measured in 2 ways: 1) as an area under the curve (AUC) over first 6 months post CAR T-cell infusion; and 2) as still having detectable CAR T-cells at 6 months post CAR T-cell infusion. AUC6mos and 6-month persistence will be compared between subjects who are and are not in CR at 6 months and 12 months. | Participants who received and infusion | Posted | | Median | Standard Deviation | months*(copies/mcg of DNA) | | 6 months, 1 Year | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: BCMA Expression | BCMA expression at specified timepoints will be determined by immunohistochemical staining of bone marrow biopsy specimens and/or flow cytometric analysis of bone marrow aspirate material, in order to assess for baseline expression and potential loss of expression post-treatment. Both percent of MM cells that stain positive as well as staining intensity will be reported. | | Not Posted | | | | | | 1 Year | | Participants | | | | |
| Other Pre-specified | Exploratory Objective 2: Immune Reconstitution (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC) | The cellular composition of marrow (B-Cells, T-Cells, Monocytes, gMDSC, mMDSC) will be quantified at the specified timepoints by flow cytometry. | Participants who received an infusion | Posted | | Median | Standard Deviation | % BMMC | | Pre-LD chemo, Day 30, 90, 180, 365 | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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| Other Pre-specified | Exploratory Objective 2: Immune Reconstitution (WBC) | The cellular composition of marrow (WBC Count) will be quantified at the specified timepoints by flow cytometry. | Participants who received an infusion | Posted | | Median | Standard Deviation | x10^3 cells/uL | | Pre-LD chemo, Day 30, 90, 180, 365 | | | | ID | Title | Description |
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| OG000 | Lenalidomide and bb2121 | Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10^6 cells. Cyclophosphamide: 300 mg/m^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis |
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