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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1202-5554 | Other Identifier | WHO | |
| 2017-002245-29 | EudraCT Number |
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This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of bb2121 | Experimental | bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bb2121 | Biological | : bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA02 CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC). | From first dose to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC. | From first dose to 24 Months |
| Time to Response |
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Inclusion Criteria:
Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Documented diagnosis of multiple myeloma
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Subjects must have measurable disease, including at least one of the criteria below:
Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. Subjects with known central nervous system involvement with myeloma. 2. History or presence of clinically relevant central nervous system (CNS) pathology.
3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5. Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating women. 13 Subject with known hypersensitivity to any component of bb2121 product, cyclophosphamide, fludarabine, or tocilizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Kristen Hege | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 108 | San Francisco | California | 94143 | United States | ||
| University of California - San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31042825 | Background | Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226. | |
| 33626253 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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137 participants treated
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| ID | Title | Description |
|---|---|---|
| FG000 | BB2121 | BB2121 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Jul 18, 2019 |
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Time from first bb2121 infusion to first documentation of response of PR or better.
| From first dose to initial response (approximately on average 1.2 months, max of 8.8 months) |
| Duration of Response | Time from first documentation of response or PR or better to first documentation of disease progression or death from any cause, whichever occurs first. | From first dose to 24 months after first dose |
| Progression Free Survival (PFS) | Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first. | From first dose to 24 months after first dose |
| Time to Progression (TTP) | Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first. | From first dose to 24 months after first dose |
| Overall Survival | Time from first bb2121 infusion to time of death due to any cause. | From screening to the end of follow up (approximately 5 years and 2 months) |
| Number of Participants With Safety Related Events | Number of participants with adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, infection and clinically signifcant laboratory abnormalities. | From screening to the end of follow up (approximately 5 years and 2 months) |
| Cmax | Cmax is defined as the maximum transgene level at Tmax Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time. | From first dose to the end of follow up (Approximately 5 years) |
| AUC 0-9M | The AUC of the transgene level from the time of dosing to 9 months | at 9 months post first dose (Approximtately 9 Months) |
| Tmax | Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time. | From first dose to the end of follow up (Approximately 5 years) |
| Number of Participants With Anti-CAR-Antibodies | Number of Participants with Anti-CAR-Antibodies. Pre-postive is defined by last value before or on bb2121 infusion date is positive Post-positve is defined by at least one positive value post bb2121 infusion. | From first dose to the end of follow up (Approximately 5 years) |
| Percentage of Participants Who Achieved >= VGPR and MRD Negative Status | Percentage of participants who achieved ≥ VGPR and MRD negative status at a sensitivity of 10-⁵ at any time point within 3 months prior to achieving at least VGPR until the time of PD/death. MRD in the bone marrow will be measured using both next generation sequencing (NGS) techniques measuring immunoglobulin gene rearrangements of the malignant clone. MRD will be reported with a sensitivity of 10-⁴, 10-⁵, and 10-⁶ nucleated cells. The primary analysis for MRD negative response will use the sensitivity of 10-⁵. MRD = Minimal Residual Disease PD = Progressive Disease VGPR = Very good partial response. | From screening to the end of follow up (Approximately 5 years and 2 months) |
| Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue. | Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-C30 - Pain | Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning | The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning | The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL | Mean change from baseline on the EORTC QLQ-C30 The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms | Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects | Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | At Day 1 and at specific time points up to month 24 |
| Mean Change From Baseline on the EQ-5D-5L Index | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. | At Day 1 and at specific time points up to month 24 |
| San Francisco |
| California |
| 94143 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Local Institution - 103 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 107 | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
| Local Institution - 106 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 105 | Rochester | Minnesota | 55905 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 102 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 109 | New York | New York | 10029 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| Local Institution - 101 | Nashville | Tennessee | 37203 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Local Institution - 104 | Dallas | Texas | 75390 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Universitaire Ziekenhuizen Leuven | Leuven | Flemish Brabant | 3000 | Belgium |
| Local Institution - 201 | Leuven | B-3000 | Belgium |
| Local Institution - 301 | Toronto | Ontario | M5G 2M9 | Canada |
| Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| Centre Hospitalier Regional Universitaire de Lille-Hopital Calude Huriez Service des Maladies du Sang | Lille | Hauts-de-France | 59037 | France |
| Centre Hospitalier Universitaire de Nantes - Hotel Dieu | Nantes | Pays de la Loire Region | 44093 | France |
| Local Institution - 402 | Lille | 59037 | France |
| Local Institution - 401 | Nantes | 44093 | France |
| Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| University of Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitatsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Local Institution - 502 | Heidelberg | 69120 | Germany |
| Local Institution - 503 | Tübingen | 72076 | Germany |
| Local Institution - 501 | Würzburg | 97080 | Germany |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico | Bologna | Emilia-Romagna | 40138 | Italy |
| Local Institution - 602 | Bergamo | 24128 | Italy |
| Ospedali Riuniti di Bergamo | Bergamo | 24128 | Italy |
| Local Institution - 601 | Bologna | 40138 | Italy |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 3290498 | Japan |
| Japan Red Cross Medical Center | Shibuya-ku | Tokyo | 150-8935 | Japan |
| Local Institution - 803 | Isehara City, Kanagawa | 259-1193 | Japan |
| Local Institution - 801 | Shibuya-ku | 150-8935 | Japan |
| Local Institution - 802 | Shimotsuke | 329-0498 | Japan |
| Local Institution - 804 | Shinjuku | 162-8666 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku | 162-8666 | Japan |
| Hospital Universitari Germans Trias i Pujol Can Ruti | Badalona | Barcelona | 08916 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Local Institution - 702 | Badalona (Barcelona) | 08916 | Spain |
| Local Institution - 701 | Pamplona | 31008 | Spain |
| Background |
| Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850. |
| 40198886 | Derived | Sidana S, Ahmed N, Akhtar OS, Brazauskas R, Oloyede T, Bye M, Hansen D, Ferreri C, Freeman CL, Afrough A, Anderson LD Jr, Dhakal B, Dhanda D, Gowda L, Hashmi H, Harrison MJ, Kitali A, Landau H, Mirza AS, Patwardhan P, Qazilbash M, Usmani S, Patel K, Nishihori T, Ganguly S, Pasquini MC. Standard-of-care idecabtagene vicleucel for relapsed/refractory multiple myeloma. Blood. 2025 Jul 10;146(2):167-177. doi: 10.1182/blood.2024026216. |
| 37087950 | Derived | Delforge M, Otero PR, Shah N, Moshkovich O, Braverman J, Dhanda DS, Lanar S, Devlen J, Miera M, Gerould H, Campbell TB, Munshi NC. Analysis of patient-reported experiences up to 2 years after receiving idecabtagene vicleucel (ide-cel, bb2121) for relapsed or refractory multiple myeloma: Longitudinal findings from the phase 2 KarMMa trial. Leuk Res. 2023 Jun;129:107074. doi: 10.1016/j.leukres.2023.107074. Epub 2023 Apr 3. |
| 36794354 | Derived | Connarn JN, Witjes H, van Zutphen-van Geffen M, de Greef R, Campbell TB, Hege K, Zhou S, Lamba M. Characterizing the exposure-response relationship of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1687-1697. doi: 10.1002/psp4.12922. Epub 2023 Feb 15. |
| 36705644 | Derived | Karampampa K, Zhang W, Venkatachalam M, Cotte FE, Dhanda D. Cost-effectiveness of idecabtagene vicleucel compared with conventional care in triple-class exposed relapsed/refractory multiple myeloma patients in Canada and France. J Med Econ. 2023 Jan-Dec;26(1):243-253. doi: 10.1080/13696998.2023.2173466. |
| 35485211 | Derived | Shah N, Mojebi A, Ayers D, Cope S, Dhanasiri S, Davies FE, Hari P, Patel P, Hege K, Dhanda D. Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. J Comp Eff Res. 2022 Jul;11(10):737-749. doi: 10.2217/cer-2022-0045. Epub 2022 Apr 29. |
| 35046063 | Derived | Sharma P, Kanapuru B, George B, Lin X, Xu Z, Bryan WW, Pazdur R, Theoret MR. FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2022 May 2;28(9):1759-1764. doi: 10.1158/1078-0432.CCR-21-3803. |
| 34933328 | Derived | Delforge M, Shah N, Miguel JSF, Braverman J, Dhanda DS, Shi L, Guo S, Yu P, Liao W, Campbell TB, Munshi NC. Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma. Blood Adv. 2022 Feb 22;6(4):1309-1318. doi: 10.1182/bloodadvances.2021005913. |
| 33619368 | Derived | Da Via MC, Dietrich O, Truger M, Arampatzi P, Duell J, Heidemeier A, Zhou X, Danhof S, Kraus S, Chatterjee M, Meggendorfer M, Twardziok S, Goebeler ME, Topp MS, Hudecek M, Prommersberger S, Hege K, Kaiser S, Fuhr V, Weinhold N, Rosenwald A, Erhard F, Haferlach C, Einsele H, Kortum KM, Saliba AE, Rasche L. Homozygous BCMA gene deletion in response to anti-BCMA CAR T cells in a patient with multiple myeloma. Nat Med. 2021 Apr;27(4):616-619. doi: 10.1038/s41591-021-01245-5. Epub 2021 Feb 22. |
| BMS Clinical Trial Patient Recruiting | View source |
| COMPLETED | completed as per protocol |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BB2121 | BB2121 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Overall Response Rate | Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC). | All Treated Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to 24 Months |
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| Secondary | Complete Response Rate | Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC. | All Treated Participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose to 24 Months |
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| Secondary | Time to Response | Time from first bb2121 infusion to first documentation of response of PR or better. | All Treated Participants with a CR or PR as per IRC | Posted | Median | Full Range | Months | From first dose to initial response (approximately on average 1.2 months, max of 8.8 months) |
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| Secondary | Duration of Response | Time from first documentation of response or PR or better to first documentation of disease progression or death from any cause, whichever occurs first. | All Treated Participants with a CR or PR as per IRC | Posted | Median | 95% Confidence Interval | Months | From first dose to 24 months after first dose |
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| Secondary | Progression Free Survival (PFS) | Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first. | All Treated Population | Posted | Median | 95% Confidence Interval | Months | From first dose to 24 months after first dose |
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| Secondary | Time to Progression (TTP) | Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first. | All Treated Population | Posted | Median | 95% Confidence Interval | Months | From first dose to 24 months after first dose |
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| Secondary | Overall Survival | Time from first bb2121 infusion to time of death due to any cause. | All Treated Population | Posted | Median | 95% Confidence Interval | Months | From screening to the end of follow up (approximately 5 years and 2 months) |
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| Secondary | Number of Participants With Safety Related Events | Number of participants with adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, infection and clinically signifcant laboratory abnormalities. | All Treated Participants | Posted | Count of Participants | Participants | From screening to the end of follow up (approximately 5 years and 2 months) |
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| Secondary | Cmax | Cmax is defined as the maximum transgene level at Tmax Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time. | PK Evaluable Population | Posted | Mean | Standard Deviation | transgene copies/ug of genomic DNA | From first dose to the end of follow up (Approximately 5 years) |
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| Secondary | AUC 0-9M | The AUC of the transgene level from the time of dosing to 9 months | PK Evaluable Population for AUC at 9 Months | Posted | Mean | Standard Deviation | copies*days/ug | at 9 months post first dose (Approximtately 9 Months) |
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| Secondary | Tmax | Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time. | PK Evaluable Population | Posted | Mean | Standard Deviation | Days | From first dose to the end of follow up (Approximately 5 years) |
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| Secondary | Number of Participants With Anti-CAR-Antibodies | Number of Participants with Anti-CAR-Antibodies. Pre-postive is defined by last value before or on bb2121 infusion date is positive Post-positve is defined by at least one positive value post bb2121 infusion. | All Treated Population | Posted | Count of Participants | Participants | From first dose to the end of follow up (Approximately 5 years) |
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| Secondary | Percentage of Participants Who Achieved >= VGPR and MRD Negative Status | Percentage of participants who achieved ≥ VGPR and MRD negative status at a sensitivity of 10-⁵ at any time point within 3 months prior to achieving at least VGPR until the time of PD/death. MRD in the bone marrow will be measured using both next generation sequencing (NGS) techniques measuring immunoglobulin gene rearrangements of the malignant clone. MRD will be reported with a sensitivity of 10-⁴, 10-⁵, and 10-⁶ nucleated cells. The primary analysis for MRD negative response will use the sensitivity of 10-⁵. MRD = Minimal Residual Disease PD = Progressive Disease VGPR = Very good partial response. | All Treated Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | From screening to the end of follow up (Approximately 5 years and 2 months) |
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| Secondary | Mean Change From Baseline on the EORTC QLQ-C30 - Fatigue. | Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
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| Secondary | Mean Change From Baseline on the EORTC QLQ-C30 - Pain | Mean change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
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| Secondary | Mean Change From Baseline on the EORTC QLQ-C30 - Physical Functioning | The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
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| Secondary | Mean Change From Baseline on the EORTC QLQ-C30 - Cognitive Functioning | The QLQ-C30 employs a week recall period for all items. All items will be scored from 0 to 100 and an average will be taken. This average is the overall score. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
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| Secondary | Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL | Mean change from baseline on the EORTC QLQ-C30 The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline on the EORTC QLQ-MY20 - Disease Symptoms | Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline on the EORTC QLQ-MY20 - Side Effects | Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. All items will be scored from 0 to 100. The average of the scores will represent the symptoms score. A high score for a symptom scale/item represents a high level of symptomatic problem. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline on the EQ-5D-5L Index | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. | PRO Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | At Day 1 and at specific time points up to month 24 |
|
|
From screening to the end of follow up (approximately 5 years and 2 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BB2121 | BB2121 | 82 | 137 | 108 | 137 | 137 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hypopyon | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Listeriosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Serratia bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Plasmablastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cauda equina syndrome | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | 1-855-907-3286 | Clinical.Trials@bms.com |
| Dec 12, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000715380 | idecabtagene vicleucel |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
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| Title |
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| Denominators |
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| Categories |
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| Title | Denominators | Categories |
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| Title |
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| Denominators |
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| Categories |
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| Title |
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| Denominators |
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| Categories |
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| Categories |
|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Any Grade AE |
| |||||
| Grade 3 or 4 AE |
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| SAEs |
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| AEs of Special Interest |
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| Cytokine Release Syndrome |
| |||||
| Neurotoxicity |
| |||||
| Infections |
| |||||
| Clinically Significant Laboratory Abnormalities |
|
| Title | Denominators | Categories |
|---|
| Total |
|
| ||||
| 450x10^6 cells |
|
| ||||
| 300x10^6 cells |
|
| ||||
| 150x10^6 cells |
|
|
| Categories |
|---|
| Total |
|
| ||||
| 450x10^6 cells |
|
| ||||
| 300x10^6 cells |
|
| ||||
| 150x10^6 cells |
|
|
| Denominators |
|---|
| Categories |
|---|
| Total |
|
| ||||
| 450x10^6 cells |
|
| ||||
| 300x10^6 cells |
|
| ||||
| 150x10^6 cells |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Pre-Positive Pre-positive and post-positive |
|
| ||||
| Pre-Positive Pre-positive and post-negative |
|
| ||||
| Pre-Positive Missing post data |
|
| ||||
| Pre-Negative Pre-negative and post-postive |
|
| ||||
| Pre-Negative Pre-negative and post-negative |
|
| ||||
| Pre-Negative Missing post data |
|
| ||||
| Missing Pre Data Post-positive |
|
| ||||
| Missing Pre Data post-negative |
|
| ||||
| Missing Pre Data missing Post Data |
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