This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma (NCT00872521), a na phase 2 study. The primary outcome is Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00872521 |
| Phase | Phase 2 |
| Condition | Multiple Myeloma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 107 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Janssen-Cilag Pty Ltd |
| Results posted | Yes |
2. Clinical Question
Population
Previously untreated patients with multiple myeloma. The primary endpoint population is described as the intent-to-treat population: enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.
Intervention
Open-label PAD induction with bortezomib, doxorubicin and dexamethasone. The regimen is described as four 21-day treatment cycles.
Comparator
No comparison group is described. The study is listed as single-group, with allocation recorded as NA, so it does not provide a randomized control comparison.
Primary question
How many participants met the registry’s definition of response after four cycles of PAD induction, assessed at 84 days?
The response definition includes stringent complete response, complete response, very good partial response or partial response, according to International Myeloma Working Group criteria. The endpoint is a count of participants who met one of those response categories; it is not a comparison of PAD with another treatment.
The study also lists secondary outcomes concerning response after induction and following autologous stem cell transplant, event-free survival, overall survival, quality of life, and response stratified by protein expression. Those additional outcomes broaden the questions being examined, but they do not change the primary question. The registry record does not report the primary responder count or a corresponding estimate of response uncertainty. It therefore does not establish, from the information recorded, the observed magnitude or precision of the primary response result.
3. Trial Design
This is a Phase II, completed, single-group study of PAD induction in previously untreated patients with multiple myeloma. The registry lists enrollment as 107 and identifies the intervention as PAD induction. The treatment is open label: masking is listed as none. Allocation is recorded as NA, and the study model is single group. Thus, the registry record describes treatment in one group rather than a randomized comparison between PAD and a control or alternative regimen.
The regimen description specifies four 21-day treatment cycles. Bortezomib is listed at 1.3 mg/m2 intravenously on D1, 4, 8 and 11; doxorubicin at 20 mg/m2 intravenously on D1 and 4; and dexamethasone at 20 mg orally on D1, 2, 4, 5, 8, 9, 11 and 12. These are regimen details, not evidence that every participant received every scheduled dose.
The primary outcome is the number of participants classified as responders after four cycles, with an 84-day timeframe. The described endpoint population includes enrolled participants who proceeded to receive Day 1 of Cycle 1. The registry lists additional response outcomes after transplant, survival outcomes, quality of life, and response analyses stratified by p53 or Cyclin D1 protein expression. The listed start is 2009-01, the primary completion is 2011-03, and the status is completed.
The record does not report a control-group result, randomization procedure, masking procedure beyond the open-label status, or a detailed statistical analysis plan. Because there is no like-for-like control comparison, observed response within the treated group cannot by itself identify what would have happened to comparable patients under another treatment or without this regimen.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 107 participants were enrolled and they all received the study treatment.
Completed PAD Induction
| Stage | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| STARTED | 26 | 72 | 9 |
| COMPLETED | 21 | 68 | 9 |
| NOT COMPLETED | 5 | 4 | 0 |
Reasons for not completing this period:
| Reason | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| Patient choice | 0 | 1 | 0 |
| Disease progression | 0 | 2 | 0 |
| Adverse Event | 4 | 0 | 0 |
| Death | 1 | 1 | 0 |
Primary Endpoint Analysis
| Stage | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| STARTED | 21 | 68 | 9 |
| COMPLETED | 20 | 63 | 8 |
| NOT COMPLETED | 1 | 5 | 1 |
Reasons for not completing this period:
| Reason | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| Other | 1 | 2 | 0 |
| Patient choice | 0 | 1 | 0 |
| Efficacy data unavailable | 0 | 2 | 0 |
| Patient response missing | 0 | 0 | 1 |
Completed 3-month Follow up
| Stage | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| STARTED | 20 | 63 | 8 |
| COMPLETED | 20 | 60 | 8 |
| NOT COMPLETED | 0 | 3 | 0 |
Reasons for not completing this period:
| Reason | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| Other | 0 | 2 | 0 |
| Physician Decision | 0 | 1 | 0 |
Secondary Endpoint Analysis
| Stage | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| STARTED | 20 | 60 | 8 |
| COMPLETED | 20 | 58 | 7 |
| NOT COMPLETED | 0 | 2 | 1 |
Reasons for not completing this period:
| Reason | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test |
|---|---|---|---|
| Efficacy data unavailable | 0 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test | Total |
|---|---|---|---|---|---|
| Participants analysed | 26 | 72 | 9 | 107 | |
| Age, Continuous | Years | 58.0 (SD 7.6) | 58.1 (SD 10.1) | 55.6 (SD 8.1) | 57.9 (SD 9.3) |
| Sex: Female, Male: Female | Participants | 9 | 26 | 4 | 39 |
| Sex: Female, Male: Male | Participants | 17 | 46 | 5 | 68 |
| Race/Ethnicity, Customized: White | Participants | 23 | 63 | 8 | 94 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 2 | 0 | 3 |
| Race/Ethnicity, Customized: Mauritian | Participants | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Indian | Participants | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Middle Eastern | Participants | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized: South American | Participants | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Appears White | Participants | 1 | 4 | 0 | 5 |
| Race/Ethnicity, Customized: Missing race | Participants | 0 | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction, measured over 84 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants who were responders after four cycles of PAD induction, assessed at 84 days. A responder is defined as having stringent complete response, complete response, very good partial response or partial response under International Myeloma Working Group criteria. The registry describes criteria based on laboratory findings, bone marrow findings and, for partial response, decreases in measured protein levels.
This endpoint converts response categories into a binary classification for each participant: meeting one of the listed response categories or not meeting one. Reporting the number of responders can describe how often the specified response threshold was reached in the analyzed population. A count is not itself a measure of uncertainty, and interpreting it usually also requires the relevant denominator and an uncertainty estimate. Those primary result details are not reported in the registry record.
Response is used as an outcome because it records change in disease measures according to prespecified clinical criteria. However, the registry entry alone does not establish the clinical implications of a response category, nor does a response count show whether the regimen caused the response. In a single-group study, the endpoint describes outcomes observed after treatment without a concurrent randomized comparator. The record also lists longer-term and other outcomes, but those are distinct from the primary response count.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome as a responder count after four cycles of PAD induction. It does not report the primary number of responders, the denominator used for that result, or an estimate of uncertainty such as a confidence interval. Consequently, the primary outcome’s magnitude and precision cannot be described from the registry record. No primary p-value or treatment-effect estimate is reported in the record.
This is a single-group study, not a randomized comparison. Even if an observed response proportion were available, it would describe the treated group’s outcomes; it would not estimate a randomized difference against another regimen. Without a concurrent comparator, differences between observed outcomes and outcomes that might have occurred under another treatment cannot be isolated from other influences. The open-label status also means that the record does not describe masking.
The registry lists secondary outcomes that include response following autologous stem cell transplant, event-free survival, overall survival, quality-of-life scores, and response analyses by protein expression. Their listing indicates planned outcome domains in the record, not that results for each are available or conclusive. The numerical results for those outcomes are not reported in the registry record posted for this analysis. The same caution applies to the listed secondary response categories: their names do not reveal how many participants experienced them.
The safety record lists serious-event terms with percentages, including Pyrexia and Pneumonia at 22.2%, Back Pain at 11.5%, and Anaemia, Herpes Zoster and Overdose at 11.1% each. These are descriptive entries. The registry record does not state the denominator or further context for these listed percentages in the registry record for interpretation. They should not be read as comparative risks or as proof that an event was caused by treatment.
In short, the record establishes the design, regimen, primary endpoint definition and some safety entries, but it does not provide the primary efficacy result needed to describe the observed response level. The design also limits causal interpretation: there is no randomized control group against which to assess the response experience.
9. Statistical Methods Explained
Statistical methods help distinguish what a study measured from what its results can support. The registry record identifies an endpoint and a design, but does not report a detailed statistical analysis plan or the primary numerical result. The explanations below are general statistical interpretation, with the study-specific details identified where relevant.
What does a binary response endpoint represent?
A binary endpoint places each participant into one of two categories for the analysis: meeting the response definition or not meeting it. Here, the listed responder categories are stringent complete response, complete response, very good partial response and partial response. The endpoint itself is a number of participants, and its interpretation depends on knowing both the count and the population denominator. The record describes the intended endpoint population as enrolled participants who proceeded to receive Day 1 of Cycle 1, but does not report the primary count or denominator result.
For a binary outcome, a response proportion can be used to describe the share of an analyzed group meeting the definition. A confidence interval, when reported, describes uncertainty around an estimate under the statistical model used. It does not mean that a particular range of individual outcomes is guaranteed, and it does not account automatically for every possible source of bias. No primary confidence interval is reported in the registry record.
Why does the single-group design matter?
In general, a control group offers a reference for comparing outcomes under different treatment strategies. Random allocation is one way to make groups comparable, on average, with respect to measured and unmeasured characteristics. This study is recorded as single group, with allocation NA, and is explicitly not a randomized comparison. There is therefore no concurrent randomized control estimate in the registry record. An outcome observed after treatment can describe what happened in the enrolled group, but it cannot by itself distinguish a treatment effect from other explanations for the outcome.
Open-label status means that masking is listed as none. In general, lack of masking can matter when outcomes involve judgment, treatment decisions, reporting or follow-up. The response criteria are specified using International Myeloma Working Group categories, but the registry entries do not describe how response assessments were administered or whether any assessment procedures reduced potential bias.
What does the analysis population describe?
The primary endpoint population is described as an intent-to-treat population consisting of enrolled participants who proceeded to receive Day 1 of Cycle 1. This is a record-specific definition. In general, analysis populations should be stated clearly because inclusion rules affect the population to which an estimate applies. The registry record does not explain how participants who did not proceed to that treatment day were handled in other analyses, or how missing endpoint assessments were treated.
For safety outcomes, the population at risk and the definition of an affected participant are important to interpretation. The available serious-event entries include group labels and counts, as well as selected terms with percentages, but the registry entries do not give further definitions of the percentage denominators. Without those details, the listed percentages should be treated as descriptive registry entries rather than interpreted as rates that can be compared across studies.
How should multiplicity be considered?
Multiplicity arises when a study assesses multiple outcomes, subgroups or statistical comparisons. In general, conducting many tests can increase the chance that at least one result appears noteworthy by chance if each test is interpreted in isolation. The registry lists 15 outcome measures and 6 analyses, as well as several secondary outcomes and protein-expression subgroup analyses. The registry record does not report a multiplicity adjustment or a hierarchy specifying which analyses were confirmatory. Without that information, isolated secondary or subgroup findings require cautious interpretation.
What do sample-size illustrations mean?
General planning calculations can illustrate the number of participants per arm needed under stated assumptions. The described illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power. They do not change the single-group design of this study or establish that the trial was designed as a two-arm comparison. The registry record does not report the study’s own sample-size justification, so the illustration assumptions should not be attributed to the trial’s original design.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures and 6 analyses. The primary outcome is the responder count after four cycles, and the record also identifies multiple secondary outcomes, including response after transplant, survival, quality of life and protein-expression subgroup analyses. Assessing multiple outcomes or subgroups can create multiplicity: in general, the more findings examined, the more likely that some may appear notable by chance. The registry record does not report whether multiplicity was addressed through an adjustment, a prespecified hierarchy, or another approach.
The primary endpoint population is described as the intent-to-treat population consisting of all enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction. This definition should be kept in view when interpreting any result attributed to the primary endpoint. The record does not report how missing primary outcome assessments were handled, whether any participants were excluded from specific analyses, or how missing data were handled for secondary outcomes. Those details are not reported in the registry record.
The terms “intent-to-treat” and “missing data” do not by themselves resolve these questions. In general, the exact population definition and the assumptions used for unavailable outcomes influence the meaning of an estimate. The registry record also does not report a detailed statistical analysis plan or a sample-size justification. Accordingly, there is no basis in the record for asserting that a particular missing-data method, multiplicity correction or interim-analysis approach was used.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 1q21 Amplified | 15 | 26 | 57.7% |
| 1q21 Not Amplified | 30 | 72 | 41.7% |
| Failed/Missing Test | 5 | 9 | 55.6% |
| Total | 50 | 107 | 46.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 1q21 Amplified | 26 of 26 |
| 1q21 Not Amplified | 72 of 72 |
| Failed/Missing Test | 9 of 9 |
| Total | 107 of 107 |
Most frequent serious adverse event terms
| Event term | Organ system | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test | Total |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 2 of 26 | 6 of 72 | 2 of 9 | 10 of 107 |
| Pyrexia | General disorders | 2 of 26 | 5 of 72 | 2 of 9 | 9 of 107 |
| Dehydration | Metabolism and nutrition disorders | 2 of 26 | 5 of 72 | 0 of 9 | 7 of 107 |
| Constipation | Gastrointestinal disorders | 0 of 26 | 6 of 72 | 0 of 9 | 6 of 107 |
| Back Pain | Musculoskeletal and connective tissue disorders | 3 of 26 | 3 of 72 | 0 of 9 | 6 of 107 |
| Nausea | Gastrointestinal disorders | 0 of 26 | 5 of 72 | 0 of 9 | 5 of 107 |
| Lower Respiratory Tract Infection | Infections and infestations | 0 of 26 | 5 of 72 | 0 of 9 | 5 of 107 |
| Diarrhoea | Gastrointestinal disorders | 0 of 26 | 3 of 72 | 0 of 9 | 3 of 107 |
| Neuropathy Peripheral | Nervous system disorders | 1 of 26 | 2 of 72 | 0 of 9 | 3 of 107 |
| Anaemia | Blood and lymphatic system disorders | 1 of 26 | 0 of 72 | 1 of 9 | 2 of 107 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 1q21 Amplified | 1q21 Not Amplified | Failed/Missing Test | Total |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 17 of 26 | 42 of 72 | 6 of 9 | 65 of 107 |
| Neuropathy Peripheral | Nervous system disorders | 15 of 26 | 36 of 72 | 3 of 9 | 54 of 107 |
| Nausea | Gastrointestinal disorders | 10 of 26 | 36 of 72 | 5 of 9 | 51 of 107 |
| Fatigue | General disorders | 7 of 26 | 30 of 72 | 4 of 9 | 41 of 107 |
| Insomnia | Psychiatric disorders | 9 of 26 | 27 of 72 | 3 of 9 | 39 of 107 |
| Diarrhoea | Gastrointestinal disorders | 9 of 26 | 26 of 72 | 3 of 9 | 38 of 107 |
| Anaemia | Blood and lymphatic system disorders | 8 of 26 | 15 of 72 | 3 of 9 | 26 of 107 |
| Dysgeusia | Nervous system disorders | 8 of 26 | 14 of 72 | 3 of 9 | 25 of 107 |
| Alopecia | Skin and subcutaneous tissue disorders | 3 of 26 | 20 of 72 | 2 of 9 | 25 of 107 |
| Rash | Skin and subcutaneous tissue disorders | 8 of 26 | 11 of 72 | 1 of 9 | 20 of 107 |
Serious events with the highest arm-level rate: pyrexia (22.2%), pneumonia (22.2%), back pain (11.5%), anaemia (11.1%), herpes zoster (11.1%).
The serious-event entries are descriptive and should be read with attention to their population and denominator. The registry lists Pyrexia and Pneumonia at 22.2%, Back Pain at 11.5%, and Anaemia, Herpes Zoster and Overdose at 11.1% each among the top serious terms. These percentages are reported as registry values; the denominator and further calculation details are not reported in the registry record.
The record also gives group breakdowns labeled 1q21 Amplified, 1q21 Not Amplified, Failed/Missing Test and Total. For the total group, the listed counts are 107 at risk and 50 affected for serious events, and 107 at risk and 107 affected for other events. The corresponding subgroup counts are recorded separately. These counts describe the registry’s event entries; the registry entries do not define further how participants were classified for these columns or whether affected participants could contribute to more than one event term.
A serious event listed in a registry is not necessarily caused by treatment, and the entries do not by themselves permit comparison with another regimen or population. The record does not report death counts in these safety groups. These figures should therefore be used as descriptive safety information, not as comparative evidence.
12. What the Result Does, and Does Not, Mean
This study asks a focused descriptive question: how many participants met the registry-defined response criteria after four cycles of PAD induction? The entry establishes that the primary endpoint was a count of responders and specifies the response categories and timeframe. However, the primary responder result is not reported in the registry record. Without that result and its denominator, the observed response level and its precision cannot be described.
The design also determines what conclusions the record can support. It is an open-label, single-group Phase II study, with allocation listed as NA. There is no randomized control group. Therefore, the study record cannot provide a randomized estimate of how response under PAD compares with response under another regimen. Even a reported response outcome in a single group would describe the outcomes observed in that group, not prove that treatment caused them.
The registry’s secondary outcomes cover response after transplant, event-free survival, overall survival, quality of life and protein-expression subgroups. These are distinct outcomes and may have different populations, timeframes and interpretation. Their inclusion in the record is not itself evidence of a particular result. Numerical results for those outcomes are not reported in the registry record for this account.
The serious-event terms and percentages likewise provide descriptive information only. Their denominators and additional context are not reported in the registry record, and the entries do not establish causation or comparative risk. Overall, the record documents the study’s design and outcome definitions, while leaving the central numerical efficacy result and several details needed for fuller statistical interpretation unreported.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between an outcome definition and an outcome result. The registry defines a primary response endpoint using established response categories and identifies its timeframe and analysis population. Those details are essential for interpreting a result, but they do not substitute for the responder count, denominator and uncertainty estimate. The primary numerical result is not reported in the registry record.
The study also illustrates why design labels matter. A single-group study can describe outcomes in the treated group, but it cannot make the same randomized comparison as a trial with a concurrent control group. Allocation is listed as NA and masking as none. A response measure may be clinically meaningful as a description of observed status, while still not identifying what would have occurred under an alternative treatment.
The listed outcomes and analyses raise familiar issues around multiplicity, subgroup interpretation and analysis populations. The registry includes survival, quality-of-life and post-transplant outcomes, as well as response analyses by protein expression. Knowing whether results were prespecified, adjusted for multiple testing, or affected by missing data is important for judging how much weight to place on individual findings. Those methods are not reported in the registry record.
Finally, safety percentages need interpretable denominators and clear definitions. The listed serious-event terms can signal what was recorded, but without the relevant context they should not be treated as comparative rates. The study therefore highlights a broader statistical lesson: reliable interpretation requires the design, endpoint, analysis population, numerical estimate and uncertainty to be read together.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting efficacy is that the registry record does not report the primary responder count, denominator result or an uncertainty estimate. It therefore does not permit a numerical description of the primary outcome’s magnitude or precision. The record also does not provide numerical results for the listed secondary outcomes in the registry record for this analysis.
The single-group design does not include a randomized comparator. This limits causal interpretation and prevents a like-for-like control comparison. The study is open label, with masking listed as none; the registry entries do not describe procedures for limiting assessment or reporting bias. Enrollment is listed as 107, but the primary endpoint population has its own definition: enrolled participants who proceeded to Day 1 of Cycle 1.
Further details needed to assess the analysis are not reported in the registry record. These include the statistical analysis plan, the study’s sample-size justification, handling of missing outcome data, and whether multiplicity was addressed. The record lists multiple outcomes and analyses, making the absence of those details relevant when interpreting any individual result.
For safety, selected serious-event terms and percentages are listed, but the percentage denominators and additional calculation context are not reported in the record. The event entries do not establish treatment causation, and the registry entries do not provide a randomized safety comparison. These limitations mean the registry entry is more informative about the study’s structure and planned outcome definitions than about comparative efficacy or risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma — NCT00872521.
- Registry record last updated 2014-05-16; status last verified 2014-05.
- Results first posted 2013-05-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed Phase II, open-label, single-group study of PAD induction in previously untreated patients with multiple myeloma. Enrollment is listed as 107. The regimen is described as four 21-day cycles of bortezomib, doxorubicin and dexamethasone.
The primary outcome is the number of participants classified as responders after four cycles, assessed at 84 days. The stated response categories are stringent complete response, complete response, very good partial response and partial response. The primary analysis population is defined as enrolled participants who proceeded to receive Day 1 of Cycle 1.
The record lists secondary response, survival, quality-of-life and protein-expression outcomes. It also lists serious-event terms and group counts. The primary numerical response result, detailed statistical analysis plan, missing-data procedures and multiplicity approach are not reported in the registry record. Because the study is single group, it does not provide a randomized control comparison.