Multiple Myeloma
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to describe contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed \[ND\] multiple myeloma (MM) and participants with relapsed/refractory \[R/R\] MM.
Detailed description
This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits. The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM: * ND MM within 3 months from initiation of treatment * R/R MM who have received 1 to 3 prior lines of therapy This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.
Interventions
OTHERNo Intervention
As this was an observational study, no intervention was administered.
Sponsors
Takeda
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Is 18 years of age or older. Is experiencing the following: 1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or 2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens. Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.
Exclusion criteria
Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion. Has participated in another study (observational or interventional) that prohibits participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants | Baseline up to 5 years | The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL. |
| Number of Participants With Myeloma Frailty Index | At Baseline | Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry. |
| Number of Participants Evaluated for Minimal Residual Disease (MRD) | Baseline up to 5 years | — |
| Number of Participants Evaluated for Gene Expression Profiling (GEP) | Baseline up to 5 years | — |
| Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | At Baseline | FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\]. |
| Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | At Baseline | ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L). |
| Duration of Treatment for Participants With and Without Stem Cell Transplant | Baseline up to 5 years | Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. |
| Overall Survival (OS) | Baseline up to 5 years | Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis. |
| Disease Progression Status on Each Regimen | Baseline up to 5 years | Disease progression status was assessed by physician interpretation of IMWG Response criteria. |
| Response to Each Regimen | Baseline up to 5 years | — |
| Time to Next Therapy | Baseline up to 5 years | The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis. |
| Number of Participants With Stem Cell Transplant | Baseline up to 5 years | — |
| Number of Participants With Co-morbidities | Baseline up to 5 years | Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use. |
| Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM) | At Baseline | Participants diagnosed with NDMM and R/RMM were determined at the start of the study. |
| Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study | Baseline up to 5 years | — |
| Sites of Disease Diagnosed With ND MM and R/R MM | Baseline up to 5 years | — |
| Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | At Baseline | ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associations Between Presentation and Disease Characteristics | Baseline up to 5 years | — |
| Associations Between Choice Of Therapy and Clinical Outcomes | Baseline up to 5 years | — |
| Number of Clinical Outcomes for Different Strategies | Baseline up to 5 years | — |
| Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy | Baseline up to 5 years | — |
| Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression | Baseline up to 5 years | — |
| Reasons for Treatment Modifications | Baseline up to 5 years | — |
| Number of Participants Receiving Different Treatment Combinations | Baseline up to 5 years | — |
| Number of Treatment Sequencing | Baseline up to 5 years | Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy. |
| Number of Participants in the Treatment Rechallenge | Baseline up to 5 years | — |
| Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | Baseline up to 5 years | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies. |
| Healthcare Resource Utilization (HRU) Among MM Participants | Baseline up to 5 years | — |
Countries
Belgium, Brazil, China, Colombia, France, Germany, Greece, Israel, Italy, Mexico, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Participants took part in the study at 130 investigative sites in China, Taiwan, Belgium, France, Germany, Greece, Israel, Italy, Spain, Turkey, United Kingdom, Brazil, Colombia, Mexico, United States from 1 July 2016 to 30 September 2021. A total of 4253 participants were enrolled in this study.
Pre-assignment details
Prospective data was collected for newly diagnosed multiple myeloma (NDMM) and Relapsed/Refractory multiple myeloma (RRMM) participants. Participants were also divided for analysis of some part of this study according to lines of therapy (LOT) they received. The final outcomes analysis performed at the end of study included 3263 participants excluding 990 participants from 4253 due to concerns around the robustness of data. Participants who received \>1 LOT were counted more than once.
Participants by arm
| Arm | Count |
|---|---|
| NDMM Participants with newly diagnosed MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years). | 2,338 |
| RRMM Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years). | 1,915 |
| Total | 4,253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change in physician or transferred to another treatment center | 72 | 62 |
| Overall Study | Deceased | 474 | 642 |
| Overall Study | Due to study discontinued at site | 100 | 85 |
| Overall Study | Lost to Follow-up | 73 | 63 |
| Overall Study | On Hospice | 20 | 26 |
| Overall Study | Patient declined participation and declined follow-up for survival | 34 | 26 |
| Overall Study | Patient withdrew consent | 64 | 58 |
| Overall Study | Physician discretion | 4 | 8 |
| Overall Study | Reason not Specified | 1,484 | 937 |
| Overall Study | Too ill to Participate | 13 | 8 |
Baseline characteristics
| Characteristic | RRMM | Total | NDMM |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 10.42 | 65.2 years STANDARD_DEVIATION 10.72 | 64.7 years STANDARD_DEVIATION 10.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 285 Participants | 633 Participants | 348 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1004 Participants | 2301 Participants | 1297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 626 Participants | 1319 Participants | 693 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 160 Participants | 390 Participants | 230 Participants |
| Race (NIH/OMB) Black or African American | 111 Participants | 264 Participants | 153 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 41 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 355 Participants | 779 Participants | 424 Participants |
| Race (NIH/OMB) White | 1273 Participants | 2779 Participants | 1506 Participants |
| Sex: Female, Male Female | 1128 Participants | 2445 Participants | 1317 Participants |
| Sex: Female, Male Male | 787 Participants | 1808 Participants | 1021 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 351 / 1,790 | 418 / 1,331 | 420 / 1,050 | 348 / 739 | 234 / 453 | 58 / 340 | 72 / 303 | 65 / 222 | 32 / 86 | 6 / 24 | 28 / 147 |
| other Total, other adverse events | 306 / 1,849 | 125 / 773 | 79 / 455 | 39 / 239 | 32 / 181 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 269 / 1,849 | 101 / 773 | 82 / 455 | 43 / 239 | 38 / 181 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Disease Progression Status on Each Regimen
Disease progression status was assessed by physician interpretation of IMWG Response criteria.
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Duration of Treatment for Participants With and Without Stem Cell Transplant
Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data.
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. Overall number analyzed are the number of participants with data available for analyses. The data is reported as per the known line of therapies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NDMM | Duration of Treatment for Participants With and Without Stem Cell Transplant | 4.5 months |
| RRMM | Duration of Treatment for Participants With and Without Stem Cell Transplant | 6.4 months |
| 3rd Line of Therapy | Duration of Treatment for Participants With and Without Stem Cell Transplant | 9.2 months |
| 4th Line of Therapy | Duration of Treatment for Participants With and Without Stem Cell Transplant | 11.5 months |
| >4th Line of Therapy | Duration of Treatment for Participants With and Without Stem Cell Transplant | 11.5 months |
Primary
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)
Participants diagnosed with NDMM and R/RMM were determined at the start of the study.
Time frame: At Baseline
Population: All Enrolled Population included all participants who signed the inform consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NDMM | Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM) | 2338 Participants |
| RRMM | Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM) | 1915 Participants |
Primary
Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)
FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 \[Del(17p)/p53\], translocation (4,14) \[t(4,14)\], and translocation (14,16) \[t(14,16)\].
Time frame: At Baseline
Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Missing | 108 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Done - Inferred | 401 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | No | 957 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Reported/Performed | 208 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Done - Inferred | 416 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | No | 950 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | No | 1007 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Done - Inferred | 399 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Missing | 109 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Yes | 50 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Missing | 107 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Yes | 126 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Reported/Performed | 208 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Reported/Performed | 208 Participants |
| NDMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Yes | 116 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Reported/Performed | 20 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Yes | 24 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Reported/Performed | 20 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Done - Inferred | 18 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Done - Inferred | 17 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Reported/Performed | 20 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | No | 144 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Yes | 7 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Done - Inferred | 18 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Yes | 23 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Missing | 480 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | No | 147 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Missing | 484 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | No | 157 Participants |
| RRMM | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Missing | 479 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | No | 63 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Reported/Performed | 7 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Yes | 12 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | No | 55 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Done - Inferred | 2 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Missing | 382 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Reported/Performed | 7 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Yes | 4 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Done - Inferred | 2 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Missing | 382 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Reported/Performed | 7 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Yes | 0 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | No | 67 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Done - Inferred | 2 Participants |
| 3rd Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Missing | 382 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Reported/Performed | 4 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | No | 24 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Missing | 213 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | No | 27 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Missing | 214 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Done - Inferred | 2 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Yes | 5 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Missing | 213 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | No | 25 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Reported/Performed | 4 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Yes | 3 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Yes | 5 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Done - Inferred | 2 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Done - Inferred | 2 Participants |
| 4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Reported/Performed | 4 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Done - Inferred | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Done - Inferred | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Missing | 68 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Missing | 68 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Reported/Performed | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Not Reported/Performed | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Not Done - Inferred | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Yes | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | No | 12 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | Missing | 68 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(14,16) | No | 12 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | Del(17p)/p53 | Yes | 0 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | No | 9 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Yes | 3 Participants |
| >4th Line of Therapy | Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH) | t(4,14) | Not Reported/Performed | 0 Participants |
Primary
Number of Participants Evaluated for Gene Expression Profiling (GEP)
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L).
Time frame: At Baseline
Population: All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage I | 395 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage II | 387 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage III | 520 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Not Available | 138 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Missing | 321 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage I | 127 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage II | 319 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage III | 76 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Not available | 69 Participants |
| NDMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Missing | 1170 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage III | 24 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage I | 236 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage I | 40 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage II | 267 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Missing | 946 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Stage III | 297 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Stage II | 145 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Not Available | 376 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | R-ISS Not available | 285 Participants |
| RRMM | Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage | ISS Missing | 264 Participants |
Primary
Number of Participants Evaluated for Minimal Residual Disease (MRD)
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Number of Participants With Co-morbidities
Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Participants With Co-morbidities | 2-3 | 307 Participants |
| NDMM | Number of Participants With Co-morbidities | >5 | 38 Participants |
| NDMM | Number of Participants With Co-morbidities | 4-5 | 66 Participants |
| NDMM | Number of Participants With Co-morbidities | Missing | 71 Participants |
| NDMM | Number of Participants With Co-morbidities | 0-1 | 1279 Participants |
| RRMM | Number of Participants With Co-morbidities | Missing | 50 Participants |
| RRMM | Number of Participants With Co-morbidities | 0-1 | 1064 Participants |
| RRMM | Number of Participants With Co-morbidities | 2-3 | 247 Participants |
| RRMM | Number of Participants With Co-morbidities | 4-5 | 60 Participants |
| RRMM | Number of Participants With Co-morbidities | >5 | 19 Participants |
Primary
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.
Time frame: At Baseline
Population: All Enrolled Population included all participants who signed informed consent. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 0 | 714 Participants |
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 1 | 727 Participants |
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 2 | 171 Participants |
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 3 | 61 Participants |
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 4 | 13 Participants |
| NDMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Missing | 75 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 4 | 2 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 0 | 710 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 3 | 22 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 1 | 559 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Missing | 34 Participants |
| RRMM | Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status | Grade 2 | 113 Participants |
Primary
Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants
The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL.
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Number of Participants With Myeloma Frailty Index
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry.
Time frame: At Baseline
Population: All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Participants With Myeloma Frailty Index | 0: Fit | 517 Participants |
| NDMM | Number of Participants With Myeloma Frailty Index | 1: Intermediate | 218 Participants |
| NDMM | Number of Participants With Myeloma Frailty Index | ≥2: Frail | 190 Participants |
| NDMM | Number of Participants With Myeloma Frailty Index | Missing | 836 Participants |
| RRMM | Number of Participants With Myeloma Frailty Index | Missing | 680 Participants |
| RRMM | Number of Participants With Myeloma Frailty Index | 0: Fit | 428 Participants |
| RRMM | Number of Participants With Myeloma Frailty Index | ≥2: Frail | 130 Participants |
| RRMM | Number of Participants With Myeloma Frailty Index | 1: Intermediate | 202 Participants |
Primary
Number of Participants With Stem Cell Transplant
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NDMM | Number of Participants With Stem Cell Transplant | 1790 Participants |
| RRMM | Number of Participants With Stem Cell Transplant | 686 Participants |
| 3rd Line of Therapy | Number of Participants With Stem Cell Transplant | 458 Participants |
| 4th Line of Therapy | Number of Participants With Stem Cell Transplant | 249 Participants |
| >4th Line of Therapy | Number of Participants With Stem Cell Transplant | 80 Participants |
Primary
Overall Survival (OS)
Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.
Time frame: Baseline up to 5 years
Population: All Enrolled Population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NDMM | Overall Survival (OS) | NA months |
| RRMM | Overall Survival (OS) | 47.67 months |
| 3rd Line of Therapy | Overall Survival (OS) | 32.07 months |
| 4th Line of Therapy | Overall Survival (OS) | 20.60 months |
| >4th Line of Therapy | Overall Survival (OS) | 13.44 months |
Primary
Response to Each Regimen
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Sites of Disease Diagnosed With ND MM and R/R MM
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Primary
Time to Next Therapy
The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NDMM | Time to Next Therapy | 30.39 months |
| RRMM | Time to Next Therapy | 15.44 months |
| 3rd Line of Therapy | Time to Next Therapy | 9.46 months |
| 4th Line of Therapy | Time to Next Therapy | 6.90 months |
| >4th Line of Therapy | Time to Next Therapy | 5.95 months |
Secondary
Associations Between Choice Of Therapy and Clinical Outcomes
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Associations Between Presentation and Disease Characteristics
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Healthcare Resource Utilization (HRU) Among MM Participants
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Number of Clinical Outcomes for Different Strategies
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Number of Participants in the Treatment Rechallenge
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.
Secondary
Number of Participants Receiving Different Treatment Combinations
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed the inform consent form. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd 3rd and 4th line of therapy. The overall number of participants analyzed is the number of participants available for analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Lenalidomide (VR) | 560 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Melphalan and Thalidomide (MT) | 10 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Lenalidomide (dara-R) | 3 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Thalidomide (VT) | 272 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and dexamethasone (KD) | 3 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Thalidomide and Dexamethasone (TD) | 7 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Lenalidomide (R) | 21 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Other Regimen (Elo-Other) | 6 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab and Lenalidomide (Elo-R) | 7 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and dexamethasone (VD) | 95 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Pomalidomide (dara-Pom) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Ixazomib (dara-I) | 1 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Lenalidomide and Dexamethasone (RD) | 86 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Lenalidomide (IR) | 4 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib (I) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Bortezomib (dara-V) | 7 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab (Dara) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Lenalidomide (KR) | 63 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Pomalidomide (Elo-Pom) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Melphalan (VM) | 75 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Cyclophosphamide and Thalidomide (CT) | 60 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Pomalidomide (VPom) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Dexamethasone (ID) | 1 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Other Regimen | 416 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Pomalidomide and Dexamethasone (PomD) | 0 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Pomalidomide (KPom) | 1 Participants |
| NDMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Cyclophosphamide (VC) | 497 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Pomalidomide (KPom) | 27 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib (I) | 6 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and dexamethasone (KD) | 59 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Bortezomib (dara-V) | 110 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Dexamethasone (ID) | 14 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Ixazomib (dara-I) | 12 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Lenalidomide (R) | 39 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Lenalidomide (dara-R) | 149 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Cyclophosphamide (VC) | 99 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Pomalidomide (dara-Pom) | 49 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Pomalidomide (Elo-Pom) | 6 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Lenalidomide and Dexamethasone (RD) | 218 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Lenalidomide (VR) | 86 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Cyclophosphamide and Thalidomide (CT) | 37 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Melphalan and Thalidomide (MT) | 3 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab and Lenalidomide (Elo-R) | 42 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Thalidomide and Dexamethasone (TD) | 1 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Thalidomide (VT) | 60 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and dexamethasone (VD) | 47 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Other Regimen | 359 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Daratumumab (Dara) | 15 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Lenalidomide (IR) | 96 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Other Regimen (Elo-Other) | 4 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Lenalidomide (KR) | 112 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Pomalidomide and Dexamethasone (PomD) | 12 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Pomalidomide (VPom) | 7 Participants |
| RRMM | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Melphalan (VM) | 16 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab and Lenalidomide (Elo-R) | 20 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Lenalidomide (VR) | 19 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Cyclophosphamide (VC) | 43 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Thalidomide (VT) | 10 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Melphalan (VM) | 8 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Lenalidomide (R) | 22 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Lenalidomide and Dexamethasone (RD) | 126 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Cyclophosphamide and Thalidomide (CT) | 11 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Melphalan and Thalidomide (MT) | 4 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Thalidomide and Dexamethasone (TD) | 5 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and dexamethasone (VD) | 18 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Lenalidomide (IR) | 115 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Lenalidomide (KR) | 42 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Pomalidomide (VPom) | 2 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Pomalidomide (KPom) | 22 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and dexamethasone (KD) | 76 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Bortezomib (dara-V) | 78 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Ixazomib (dara-I) | 7 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Lenalidomide (dara-R) | 70 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Pomalidomide (dara-Pom) | 72 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Dexamethasone (ID) | 13 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib (I) | 5 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Pomalidomide and Dexamethasone (PomD) | 66 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab (Dara) | 21 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Pomalidomide (Elo-Pom) | 10 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Other Regimen (Elo-Other) | 4 Participants |
| 3rd Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Other Regimen | 390 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Pomalidomide (KPom) | 12 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Other Regimen | 380 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib (I) | 4 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Pomalidomide (VPom) | 6 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and Lenalidomide (KR) | 18 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Other Regimen (Elo-Other) | 1 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Pomalidomide and Dexamethasone (PomD) | 39 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Lenalidomide (IR) | 34 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and dexamethasone (VD) | 6 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Cyclophosphamide (VC) | 18 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab (Dara) | 56 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Thalidomide and Dexamethasone (TD) | 2 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Melphalan and Thalidomide (MT) | 3 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Cyclophosphamide and Thalidomide (CT) | 5 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab and Lenalidomide (Elo-R) | 10 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Lenalidomide and Dexamethasone (RD) | 30 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Lenalidomide (R) | 5 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Lenalidomide (VR) | 10 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Elotuzumab-Pomalidomide (Elo-Pom) | 14 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Lenalidomide (dara-R) | 31 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Melphalan (VM) | 3 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Pomalidomide (dara-Pom) | 43 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Ixazomib (dara-I) | 3 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Daratumumab-Bortezomib (dara-V) | 46 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Bortezomib and Thalidomide (VT) | 11 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Ixazomib and Dexamethasone (ID) | 9 Participants |
| 4th Line of Therapy | Number of Participants Receiving Different Treatment Combinations | Carfilzomib and dexamethasone (KD) | 46 Participants |
Secondary
Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
Time frame: Baseline up to 5 years
Population: Participants who received Takeda products and signed informed consent form were included in the analysis. As pre-specified in SAP, data for treatment-emergent adverse events was planned to be collected and reported for Takeda products only. Participants were counted more than once in each line of therapy towards the total. The data is reported as per the known line of therapies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NDMM | Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | 375 Participants |
| RRMM | Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | 275 Participants |
| 3rd Line of Therapy | Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | 178 Participants |
| 4th Line of Therapy | Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | 98 Participants |
| >4th Line of Therapy | Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation | 95 Participants |
Secondary
Number of Treatment Sequencing
Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed informed consent. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd and 3rd line of therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Number of Treatment Sequencing | PI/alkylator based | 351 Participants |
| NDMM | Number of Treatment Sequencing | mAB/alkalytor based | 2 Participants |
| NDMM | Number of Treatment Sequencing | Unknown | 1490 Participants |
| NDMM | Number of Treatment Sequencing | PI/IMID based | 608 Participants |
| NDMM | Number of Treatment Sequencing | mAB/PI based | 156 Participants |
| NDMM | Number of Treatment Sequencing | mAB based | 41 Participants |
| NDMM | Number of Treatment Sequencing | IMID based | 515 Participants |
| NDMM | Number of Treatment Sequencing | mAB/IMID based | 290 Participants |
| NDMM | Number of Treatment Sequencing | IMID/alkylator based | 123 Participants |
| NDMM | Number of Treatment Sequencing | Alkylator based | 79 Participants |
| NDMM | Number of Treatment Sequencing | Cytotoxic | 74 Participants |
| NDMM | Number of Treatment Sequencing | PI/IMID/alkylator based | 34 Participants |
| NDMM | Number of Treatment Sequencing | PI based | 366 Participants |
| NDMM | Number of Treatment Sequencing | mAB/IMID/PI based | 36 Participants |
| NDMM | Number of Treatment Sequencing | Other | 59 Participants |
| RRMM | Number of Treatment Sequencing | Alkylator based | 40 Participants |
| RRMM | Number of Treatment Sequencing | PI/IMID based | 295 Participants |
| RRMM | Number of Treatment Sequencing | PI/alkylator based | 137 Participants |
| RRMM | Number of Treatment Sequencing | IMID/alkylator based | 119 Participants |
| RRMM | Number of Treatment Sequencing | PI/IMID/alkylator based | 14 Participants |
| RRMM | Number of Treatment Sequencing | Other | 32 Participants |
| RRMM | Number of Treatment Sequencing | Unknown | 1057 Participants |
| RRMM | Number of Treatment Sequencing | mAB based | 77 Participants |
| RRMM | Number of Treatment Sequencing | mAB/IMID based | 213 Participants |
| RRMM | Number of Treatment Sequencing | mAB/PI based | 119 Participants |
| RRMM | Number of Treatment Sequencing | mAB/alkalytor based | 7 Participants |
| RRMM | Number of Treatment Sequencing | mAB/IMID/PI based | 14 Participants |
| RRMM | Number of Treatment Sequencing | Cytotoxic | 59 Participants |
| RRMM | Number of Treatment Sequencing | IMID based | 361 Participants |
| RRMM | Number of Treatment Sequencing | PI based | 204 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | mAB/alkalytor based | 6 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | PI/IMID/alkylator based | 7 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | mAB/PI based | 69 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | mAB/IMID/PI based | 12 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | IMID/alkylator based | 57 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | PI based | 101 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | Cytotoxic | 49 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | PI/alkylator based | 57 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | mAB based | 129 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | Alkylator based | 33 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | mAB/IMID based | 128 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | Unknown | 807 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | IMID based | 118 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | Other | 46 Participants |
| 3rd Line of Therapy | Number of Treatment Sequencing | PI/IMID based | 115 Participants |
Secondary
Reasons for Treatment Modifications
Time frame: Baseline up to 5 years
Population: All Enrolled Population included all participants who signed informed consent. Participants received more than one LOT and are counted in more than one LOT. The data is reported as per the known line of therapies. Participants were counted multiple times in different categories. The overall number of participants analyzed is the number of participants available for analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NDMM | Reasons for Treatment Modifications | COVID-19 Restrictions | 13 Participants |
| NDMM | Reasons for Treatment Modifications | Lack of Response | 16 Participants |
| NDMM | Reasons for Treatment Modifications | Treatment Fatigue | 25 Participants |
| NDMM | Reasons for Treatment Modifications | COVID-19 Diagnosis (Suspected Positive) | 3 Participants |
| NDMM | Reasons for Treatment Modifications | Planned Change | 386 Participants |
| NDMM | Reasons for Treatment Modifications | Adverse Event Related to Drug | 920 Participants |
| NDMM | Reasons for Treatment Modifications | Relapse - Symptomatic/Clinical Progression | 5 Participants |
| NDMM | Reasons for Treatment Modifications | Adverse Event Not Related to MM Therapy Drug | 234 Participants |
| NDMM | Reasons for Treatment Modifications | COVID-19 Diagnosis (Confirmed Positive) | 5 Participants |
| NDMM | Reasons for Treatment Modifications | Current Dose Tolerated, Dose Increased | 110 Participants |
| NDMM | Reasons for Treatment Modifications | Missing | 6 Participants |
| NDMM | Reasons for Treatment Modifications | Relapse - Biochemical Progression | 9 Participants |
| NDMM | Reasons for Treatment Modifications | Dose Delay Due to Toxicity | 63 Participants |
| NDMM | Reasons for Treatment Modifications | Other | 425 Participants |
| NDMM | Reasons for Treatment Modifications | Patient/Family Preference | 53 Participants |
| RRMM | Reasons for Treatment Modifications | Relapse - Biochemical Progression | 17 Participants |
| RRMM | Reasons for Treatment Modifications | Patient/Family Preference | 58 Participants |
| RRMM | Reasons for Treatment Modifications | Other | 333 Participants |
| RRMM | Reasons for Treatment Modifications | Lack of Response | 23 Participants |
| RRMM | Reasons for Treatment Modifications | Current Dose Tolerated, Dose Increased | 107 Participants |
| RRMM | Reasons for Treatment Modifications | Adverse Event Not Related to MM Therapy Drug | 243 Participants |
| RRMM | Reasons for Treatment Modifications | Treatment Fatigue | 36 Participants |
| RRMM | Reasons for Treatment Modifications | Dose Delay Due to Toxicity | 91 Participants |
| RRMM | Reasons for Treatment Modifications | Adverse Event Related to Drug | 676 Participants |
| RRMM | Reasons for Treatment Modifications | COVID-19 Diagnosis (Suspected Positive) | 0 Participants |
| RRMM | Reasons for Treatment Modifications | Missing | 13 Participants |
| RRMM | Reasons for Treatment Modifications | COVID-19 Diagnosis (Confirmed Positive) | 11 Participants |
| RRMM | Reasons for Treatment Modifications | Planned Change | 274 Participants |
| RRMM | Reasons for Treatment Modifications | COVID-19 Restrictions | 21 Participants |
| RRMM | Reasons for Treatment Modifications | Relapse - Symptomatic/Clinical Progression | 10 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Treatment Fatigue | 33 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Adverse Event Related to Drug | 459 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Other | 248 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Planned Change | 205 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Adverse Event Not Related to MM Therapy Drug | 179 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Current Dose Tolerated, Dose Increased | 105 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Dose Delay Due to Toxicity | 65 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Patient/Family Preference | 39 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Lack of Response | 27 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | COVID-19 Restrictions | 22 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Relapse - Biochemical Progression | 19 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Confirmed Positive) | 7 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Relapse - Symptomatic/Clinical Progression | 3 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Suspected Positive) | 1 Participants |
| 3rd Line of Therapy | Reasons for Treatment Modifications | Missing | 4 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Relapse - Biochemical Progression | 11 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Planned Change | 99 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Restrictions | 11 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Relapse - Symptomatic/Clinical Progression | 2 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Current Dose Tolerated, Dose Increased | 47 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Adverse Event Not Related to MM Therapy Drug | 91 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Other | 110 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Missing | 2 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Treatment Fatigue | 17 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Adverse Event Related to Drug | 240 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Confirmed Positive) | 8 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Patient/Family Preference | 19 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Suspected Positive) | 0 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Lack of Response | 11 Participants |
| 4th Line of Therapy | Reasons for Treatment Modifications | Dose Delay Due to Toxicity | 32 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Lack of Response | 13 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Suspected Positive) | 0 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Restrictions | 8 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Current Dose Tolerated, Dose Increased | 30 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Adverse Event Related to Drug | 187 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Relapse - Biochemical Progression | 7 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Adverse Event Not Related to MM Therapy Drug | 62 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | COVID-19 Diagnosis (Confirmed Positive) | 3 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Planned Change | 62 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Missing | 1 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Relapse - Symptomatic/Clinical Progression | 3 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Other | 81 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Treatment Fatigue | 13 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Patient/Family Preference | 16 Participants |
| >4th Line of Therapy | Reasons for Treatment Modifications | Dose Delay Due to Toxicity | 22 Participants |
Secondary
Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
Time frame: Baseline up to 5 years
Population: As the study was early terminated data was not collected for this outcome measure.