A Phase 2 interventional study of bb2121 in Multiple Myeloma, sponsored by Celgene. Completed at 48 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 149 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted before Celgene became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility is determined prior to leukapheresis. Subjects must satisfy the following criteria to be enrolled in the study:
Documented diagnosis of multiple myeloma
Subjects must have , including at least one of the criteria below:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: bb2121
: 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).
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).
Time frame: From first dose to 24 Months
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.
Time frame: From first dose to 24 Months
Time to Response
Time from first bb2121 infusion to first documentation of response of PR or better.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From first dose to 24 months after first dose
Overall Survival
Time from first bb2121 infusion to time of death due to any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 1 and at specific time points up to month 24
| Milestone | BB2121 |
|---|---|
| Started | 137 |
| Completed | 36 |
| Not completed | 101 |
| Withdrew: Death | 77 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 20 |
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).
| Percentage of Participants | BB2121 |
|---|---|
| Overall Response Rate | 74.5 (67.1 to 81.8) |
Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC.
| Percentage of participants | BB2121 |
|---|---|
| Complete Response Rate | 34.3 (26.4 to 42.3) |
Time from first bb2121 infusion to first documentation of response of PR or better.
| Months | BB2121 |
|---|---|
| Time to Response | 1.0 (0.5 to 8.8) |
Time from first documentation of response or PR or better to first documentation of disease progression or death from any cause, whichever occurs first.
| Months | BB2121 |
|---|---|
| Duration of Response | 11.04 (9.92 to 12.52) |
Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
| Months | BB2121 |
|---|---|
| Progression Free Survival (PFS) | 8.90 (6.01 to 11.86) |
Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
| Months | BB2121 |
|---|---|
| Time to Progression (TTP) | 10.38 (6.11 to 12.06) |
Time from first bb2121 infusion to time of death due to any cause.
| Months | BB2121 |
|---|---|
| Overall Survival | 28.25 (20.21 to 38.08) |
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.
| Participants | BB2121 |
|---|---|
| Any Grade AE | 137 |
| Grade 3 or 4 AE | 136 |
| SAEs | 98 |
| AEs of Special Interest | 136 |
| Cytokine Release Syndrome | 116 |
| Neurotoxicity | 53 |
| Infections | 95 |
| Clinically Significant Laboratory Abnormalities | 0 |
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.
| transgene copies/ug of genomic DNA | BB2121 |
|---|---|
| Total | 388150.65 ± 372280.64 |
| 450x10^6 cells | 449826.92 ± 375293.18 |
| 300x10^6 cells | 335916.20 ± 369546.39 |
| 150x10^6 cells | 317793.50 ± 284926.30 |
The AUC of the transgene level from the time of dosing to 9 months
| copies*days/ug | BB2121 |
|---|---|
| Total | 8634034.70 ± 9909488.82 |
| 450x10^6 cells | 10599751.18 ± 10833877.42 |
| 300x10^6 cells | 6604279.35 ± 8523928.48 |
| 150x10^6 cells | 10555200.59 ± 13555457.13 |
Tmax: The time of maximum observed transgene level, obtained directly from the observed transgene level - time.
| Days | BB2121 |
|---|---|
| Total | 12.07 ± 4.114 |
| 450x10^6 cells | 12.37 ± 4.513 |
| 300x10^6 cells | 11.74 ± 3.830 |
| 150x10^6 cells | 13.25 ± 1.500 |
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.
| Participants | BB2121 |
|---|---|
| Pre-Positive Pre-positive and post-positive | 6 |
| Pre-Positive Pre-positive and post-negative | 0 |
| Pre-Positive Missing post data | 0 |
| Pre-Negative Pre-negative and post-postive | 69 |
| Pre-Negative Pre-negative and post-negative | 60 |
| Pre-Negative Missing post data | 1 |
| Missing Pre Data Post-positive | 1 |
| Missing Pre Data post-negative | 0 |
| Missing Pre Data missing Post Data | 0 |
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.
| Percentage of Participants | BB2121 |
|---|---|
| 10^(-4) Sensitivity | 41.6 (33.3 to 50.3) |
| 10^(-5) Sensitivity | 40.9 (32.6 to 49.6) |
| 10^(-6) Sensitivity | 24.8 (17.8 to 32.9) |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | 4.4 ± 18.56 |
| Month 1 | 1.1 ± 24.38 |
| Month 3 | -10.1 ± 24.32 |
| Month 6 | -15.1 ± 24.39 |
| Month 9 | -21.5 ± 24.58 |
| Month 12 | -16.4 ± 25.02 |
| Month 18 | -18.4 ± 19.10 |
| Month 24 | -7.9 ± 15.97 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | -3.8 ± 19.46 |
| Month 1 | -8.9 ± 26.02 |
| Month 3 | -12.0 ± 26.65 |
| Month 6 | -14.5 ± 26.15 |
| Month 9 | -17.5 ± 24.26 |
| Month 12 | -17.3 ± 26.05 |
| Month 18 | -16.7 ± 25.39 |
| Month 24 | -13.1 ± 16.25 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | -0.4 ± 18.13 |
| Month 1 | 2.1 ± 22.27 |
| Month 3 | 9.8 ± 18.54 |
| Month 6 | 13.9 ± 18.47 |
| Month 9 | 13.1 ± 19.02 |
| Month 12 | 13.3 ± 19.16 |
| Month 18 | 12.8 ± 15.99 |
| Month 24 | 3.8 ± 13.77 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | -0.4 ± 16.66 |
| Month 1 | 2.8 ± 20.10 |
| Month 3 | 5.4 ± 17.42 |
| Month 6 | 6.4 ± 16.55 |
| Month 9 | 6.8 ± 14.88 |
| Month 12 | 4.2 ± 17.63 |
| Month 18 | 3.8 ± 19.61 |
| Month 24 | 3.6 ± 16.25 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | -4.7 ± 17.03 |
| Month 1 | 4.3 ± 19.95 |
| Month 3 | 8.8 ± 20.31 |
| Month 6 | 12.5 ± 19.12 |
| Month 9 | 15.7 ± 20.88 |
| Month 12 | 14.1 ± 21.57 |
| Month 18 | 10.6 ± 17.25 |
| Month 24 | 7.1 ± 14.93 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | -0.8 ± 14.11 |
| Month 1 | -10.2 ± 18.54 |
| Month 3 | -10.8 ± 20.32 |
| Month 6 | -12.6 ± 20.81 |
| Month 9 | -14.4 ± 20.29 |
| Month 12 | -15.7 ± 23.28 |
| Month 18 | -12.0 ± 20.47 |
| Month 24 | -13.1 ± 19.07 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | 2.5 ± 9.51 |
| Month 1 | 0.0 ± 11.95 |
| Month 3 | -2.6 ± 11.45 |
| Month 6 | -4.7 ± 10.16 |
| Month 9 | -6.5 ± 10.28 |
| Month 12 | -4.0 ± 11.87 |
| Month 18 | -3.4 ± 9.96 |
| Month 24 | -3.2 ± 7.98 |
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.
| Score on a Scale | BB2121 |
|---|---|
| Day 1 | 0.0314 ± 0.1760 |
| Month 1 | 0.0528 ± 0.2473 |
| Month 3 | 0.0998 ± 0.1956 |
| Month 6 | 0.0974 ± 0.1798 |
| Month 9 | 0.1067 ± 0.2334 |
| Month 12 | 0.1097 ± 0.2287 |
| Month 18 | 0.1101 ± 0.2027 |
| Month 24 | 0.0383 ± 0.1604 |
Collected over From screening to the end of follow up (approximately 5 years and 2 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BB2121 | 82/137 (59.9%) | 108/137 (78.8%) | 137/137 (100%) |
| Event | BB2121 |
|---|---|
| General physical health deteriorationGeneral disorders | 30/137 |
| Cytokine release syndromeImmune system disorders | 22/137 |
| PneumoniaInfections and infestations | 15/137 |
| Febrile neutropeniaBlood and lymphatic system disorders | 12/137 |
| ThrombocytopeniaBlood and lymphatic system disorders | 9/137 |
| PyrexiaGeneral disorders | 8/137 |
| SepsisInfections and infestations | 7/137 |
| NeutropeniaBlood and lymphatic system disorders | 6/137 |
| InfluenzaInfections and infestations | 5/137 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/137 |
| Event | BB2121 |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 130/137 |
| Cytokine release syndromeImmune system disorders | 110/137 |
| AnaemiaBlood and lymphatic system disorders | 104/137 |
| ThrombocytopeniaBlood and lymphatic system disorders | 95/137 |
| NauseaGastrointestinal disorders | 85/137 |
| LeukopeniaBlood and lymphatic system disorders | 70/137 |
| DiarrhoeaGastrointestinal disorders | 61/137 |
| HypokalaemiaMetabolism and nutrition disorders | 56/137 |
| FatigueGeneral disorders | 53/137 |
| LymphopeniaBlood and lymphatic system disorders | 49/137 |
| Age, Continuous(Years) | BB2121 |
|---|---|
| Mean | 59.4 ± 9.53 |
| Sex: Female, Male(Participants) | BB2121 |
|---|---|
| Female | 54 |
| Male | 83 |
| Ethnicity (NIH/OMB)(Participants) | BB2121 |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 112 |
| Unknown or Not Reported | 14 |
| Race (NIH/OMB)(Participants) | BB2121 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 103 |
| More than one race | 0 |
| Unknown or Not Reported | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Dec 2023, 72 months.
Results were first posted in May 2025, 1 year 5 months after primary completion.
Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's 72 months is above that.
Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Idecabtagene vicleucel