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 Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT04126200), a randomized phase 1, phase 2 study. The primary outcome is Number of Participants Randomized Across Sub-studies.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04126200 |
| Phase | Phase 1, Phase 2 |
| Condition | Multiple Myeloma |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 208 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Participants with relapsed/refractory multiple myeloma who passed screening and were randomized. The primary endpoint population is described as all participants who passed screening and were randomized; further eligibility details are not reported in the registry record.
Intervention
The platform evaluates belantamab mafodotin alone and in combinations with other anti-cancer treatments. The listed drugs include GSK3174998, feladilimab, nirogacestat, dostarlimab, isatuximab, lenalidomide and dexamethasone. Arm descriptions also name pomalidomide in combination cohorts.
Comparator
The registry describes a randomized platform with dose-exploration sub-studies and cohort expansions, but does not provide a primary endpoint comparison between named arms. A specific comparator for the primary endpoint is not reported in the registry record.
Primary question
How many participants who passed screening were randomized across the sub-studies by Day 1? The primary endpoint is a count, not a measure of tumor response, survival, or comparative treatment effect.
The clinical context is relapsed/refractory multiple myeloma, and the registry describes belantamab mafodotin as an antibody-drug conjugate containing a humanized anti-BCMA monoclonal antibody. The study is designed to evaluate belantamab mafodotin as monotherapy and in combinations. Its platform structure allows multiple treatment combinations to be evaluated under a single master protocol as sub-studies.
That broad purpose should be distinguished from what the posted primary endpoint can establish. The endpoint counts participants randomized across sub-studies. It does not report whether participants responded, how long any response lasted, whether outcomes differed by treatment, or which regimen had a favorable balance of outcomes. Those results are not reported in the registry record. The primary endpoint therefore answers a question about enrollment into randomized study groups rather than a clinical efficacy question.
The registry gives an overall enrollment of 208, while the primary endpoint description refers specifically to participants who passed screening and were randomized. These are distinct descriptors; the randomized count for the primary endpoint is not reported in the registry record. A comparison of efficacy or safety between treatments cannot be drawn from this endpoint alone.
3. Trial Design
DREAMM 5 is a phase I/II, randomized, open-label platform study. It uses a master protocol and evaluates multiple treatment combinations as sub-studies. The registry classifies its model as sequential and its allocation as randomized; masking is listed as none. The overall enrollment is 208, and the listed status is active, not recruiting.
The registry lists dose-exploration sub-studies combining belantamab mafodotin with GSK3174998, feladilimab, nirogacestat, dostarlimab or isatuximab. It also lists combination cohorts involving nirogacestat with lenalidomide and dexamethasone, and nirogacestat with pomalidomide and dexamethasone. Monotherapy and cohort-expansion arms are also described. The intervention list names belantamab mafodotin, GSK3174998, feladilimab, nirogacestat, dostarlimab, isatuximab, lenalidomide and dexamethasone; pomalidomide appears in arm descriptions. Doses, allocation ratios, and the detailed rules governing assignment to each sub-study are not reported in the registry record.
The primary outcome is a count of participants who passed screening and were randomized across sub-studies, with a timeframe of Day 1. This is a descriptive enrollment endpoint rather than a treatment-effect endpoint. Although the study is randomized, the posted primary outcome does not specify a two-arm contrast. The registry indicates that there are no analyses for this primary outcome and that fewer than two arms are available in it. Consequently, an arm-level treatment estimate or comparison cannot be interpreted from the primary outcome.
The registry lists a study start of 2019-10-07 and a primary completion date of 2025-04-17. The record does not report a detailed statistical analysis plan, randomization sequence, stratification factors, or the intended size of each sub-study. Those design details should not be inferred from the platform label or the overall enrollment figure.
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: A total of 271 participants started the overall study which includes all participants who were screened for eligibility prior to enrollment. 208 participants met eligibility criteria and were randomized in the sub-studies.
Overall Study
| Stage | All Screened Participants |
|---|---|
| STARTED | 271 |
| COMPLETED | 208 |
| NOT COMPLETED | 63 |
Reasons for not completing this period:
| Reason | All Screened Participants |
|---|---|
| Screen Failed | 62 |
| Completed screening but not randomized to sub study | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants who passed screening and were randomized.
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 | All Screened Participants |
|---|---|---|
| Participants analysed | 271 | |
| Age, Continuous | YEARS | 67.1 (SD 8.89) |
| Sex: Female, Male: Female | Participants | 122 |
| Sex: Female, Male: Male | Participants | 149 |
| Race/Ethnicity, Customized: Asian | Participants | 46 |
| Race/Ethnicity, Customized: White | Participants | 209 |
| Race/Ethnicity, Customized: All Other Races | Participants | 12 |
| Race/Ethnicity, Customized: Missing | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Randomized Across Sub-studies, measured over Day 1.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants who passed screening and were randomized across the sub-studies, measured at Day 1. It is a count: it records how many people entered randomized study groups under the endpoint’s stated population definition. The registry does not provide a numerical endpoint result, so the count itself is not reported in the registry record.
A count of randomized participants can describe the extent of enrollment into the study’s randomized sub-studies. In a platform trial, this can be a useful operational measure because multiple treatment combinations are studied under a shared master protocol. It also identifies the population relevant to the randomized portion of the study, as distinct from all people screened or the overall enrollment figure.
However, this endpoint does not measure participants’ disease status after treatment, treatment response, time to an event, or adverse outcomes. It cannot by itself show whether one treatment combination differs from another. Those are separate clinical outcomes and would require their own definitions, follow-up periods, and analyses. Such comparative results are not reported in the registry record for the primary endpoint.
The registry states that the endpoint population includes all participants who passed screening and were randomized. The overall enrollment is 208, but the record does not state that this is the randomized count for this endpoint. The endpoint count should therefore not be treated as interchangeable with overall enrollment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome defines a straightforward quantity: the number of participants who passed screening and were randomized across sub-studies by Day 1. It is a count, not an estimate of treatment effect. The registry record does not give a numerical value for this endpoint. Although overall enrollment is listed as 208, the randomized count for the endpoint is not reported in the registry record, and the two quantities should not be assumed to be identical.
The record also lists zero analyses for the primary outcome and notes that fewer than two arms are available in that outcome. That means the posted endpoint does not supply an arm-to-arm contrast. No treatment effect estimate, confidence interval, or p-value for a comparison is reported in the registry record. Without such a contrast, there is no basis in this endpoint to judge the size or precision of differences between treatment groups.
Randomized allocation is part of the overall trial design, but randomization alone does not turn a count endpoint into an efficacy comparison. The endpoint summarizes how many participants entered randomized sub-studies, not what happened to those participants after assignment. The platform’s list of monotherapy, dose-exploration and combination cohorts describes the study structure, but it does not supply outcome findings for those cohorts.
The registry’s safety fields list an “All Screened Participants” group, with zero values for serious adverse events at risk, serious adverse events affected, other adverse events at risk, other adverse events affected, and deaths. Because the at-risk fields are also zero, these entries do not establish that no adverse events occurred among enrolled or treated participants. The record does not report an informative safety denominator or detailed safety results in those fields.
The statistical interpretation is therefore limited to the endpoint definition and the information available in the record. It does not establish the number randomized, differences between arms, or clinical outcomes. A posted overall enrollment figure cannot substitute for an endpoint result, and the absence of a reported comparison should not be interpreted as evidence of equal outcomes or of no treatment effect.
9. Statistical Methods Explained
The statistical material associated with this study must be read in light of the endpoint’s form. The primary outcome is a count of participants randomized after passing screening. It is not a continuous measurement such as a laboratory value, nor a time-to-event outcome. More importantly, the registry gives no numerical result for the count and no arm-specific analysis for it. Statistical methods that require a treatment contrast therefore cannot be applied to this primary endpoint using the posted record.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. When treatment outcomes are compared between randomized groups, this can reduce systematic differences in measured and unmeasured baseline characteristics, on average. It does not guarantee that every group is identical, and it does not itself provide evidence about treatment outcomes. A treatment comparison still requires defined outcomes, follow-up information, an analysis population, and an estimate of the difference with an appropriate measure of uncertainty.
The registry classifies DREAMM 5 as randomized and open-label, with no masking. Open-label means the registry does not describe masking of treatment assignment. The particular randomization procedure, allocation ratios, stratification factors, and procedures for assignment across the platform sub-studies are not reported in the registry record. The endpoint itself is a count across sub-studies, not an outcome contrast between randomized groups.
How should a confidence interval be understood?
In general, a confidence interval describes the statistical uncertainty around an estimated quantity under a specified analysis and its assumptions. For a treatment comparison, it can show which effect sizes are reasonably compatible with the data and model. The width of an interval is affected by factors such as the amount of information available and the variability of the outcome. An interval does not correct for bias in outcome measurement, missing data, or a poorly chosen analysis.
No confidence interval for a primary-outcome treatment comparison is reported in the registry record. Because the primary outcome has no reported two-arm analysis, there is no posted comparative estimate for which to interpret a confidence interval. A numerical endpoint count is also not reported, so the endpoint cannot be described more precisely than its definition.
Why do the listed sample-size assumptions not establish a trial design?
In general, a sample-size calculation is a planning tool for a specified comparison. It depends on assumptions about the effect to detect, the significance level, allocation, outcome distribution, and desired power. A planning illustration based on an observed effect is not the trial’s original design justification, and it is not observed power. The registry’s general sample-size description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. For time-to-event calculations it describes total events; for other calculations it describes participants per arm.
Those assumptions do not establish the planned sample size or analysis for DREAMM 5. The primary endpoint is a count across sub-studies, and the registry notes that fewer than two arms are available in that outcome. No arm-based sample-size illustration for a primary endpoint comparison is supported by the posted endpoint information. The sample-size assumptions should not be read as proof of the number planned or enrolled in any individual sub-study.
What does over-dispersion mean in general?
For count outcomes, statistical models may assume a particular relationship between the average count and its variability. Over-dispersion means the observed variability is greater than that assumed by a simpler model. If it is ignored, standard errors can be too small and confidence intervals too narrow. Whether over-dispersion is relevant depends on the outcome structure and analysis. The registry does not report a model for the primary count endpoint, a dispersion estimate, or an analysis that would allow this issue to be assessed. It would therefore be inappropriate to claim that over-dispersion was tested or addressed.
The registry lists no primary-outcome analyses. It does not report a statistical analysis plan, model specification, covariate adjustment, interim analyses, or decision rules. These details are not reported in the registry record. The posted data support a description of the endpoint and design, but not a reconstruction of the planned or executed statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The platform evaluates several treatment combinations, including monotherapy, dose-exploration sub-studies, and cohort expansions. When multiple treatment comparisons or endpoints are tested, the chance of at least one false-positive result can increase if the analyses are treated as independent tests without adjustment. In general, multiplicity approaches can control error rates or organize comparisons into a prespecified testing sequence. The appropriate approach depends on the trial’s questions and analysis plan.
A multiplicity strategy for DREAMM 5 is not reported in the registry record. The sequential platform model does not by itself reveal whether comparisons were adjusted, prioritized, or governed by decision rules. Interim analyses and any criteria for adding, continuing, or stopping sub-studies are also not reported in the registry record. No comparative primary-outcome analyses are listed, so there are no posted primary-endpoint p-values to interpret in a multiplicity framework.
The endpoint population is described as all participants who passed screening and were randomized. The registry does not report missing-data handling, exclusions after randomization, or analysis populations for clinical efficacy and safety outcomes. The number randomized for the primary endpoint is not reported. The overall enrollment figure of 208 does not fill in those details or establish how many participants contributed to any particular analysis.
In general, missing-data methods matter because the reason and timing of missing observations can affect interpretation. A complete-case analysis, imputation strategy, or other method would require a prespecified definition and assumptions. None is reported for the outcomes in this record. It is not possible to assess whether missingness was balanced across groups or whether sensitivity analyses were conducted. These reporting gaps limit evaluation of multiplicity, analysis populations, and the robustness of any treatment comparisons.
11. What the Result Does, and Does Not, Mean
The result described by the primary endpoint is a count of participants who passed screening and were randomized across sub-studies on Day 1. This endpoint can characterize enrollment into the randomized platform. The registry does not report the count itself, so the result cannot be stated numerically from the record. The overall enrollment of 208 is a separate registry figure and should not be substituted for the randomized count.
This endpoint does not show whether belantamab mafodotin, alone or in combination, changed disease outcomes. It does not report tumor response, duration of response, survival, or comparative adverse-event outcomes. The registry’s primary outcome section lists no analyses and does not provide a comparison between two arms. Accordingly, no treatment difference, confidence interval, or p-value can be interpreted for this endpoint.
The record identifies the study as a randomized, open-label phase I/II platform and names several treatment combinations and cohort expansions. These design features describe how the study is organized; they are not findings about the relative performance of the treatments. The registry’s safety entries contain zeros in the listed fields, including zero participants at risk for the adverse-event counts. Those entries do not provide an adequate basis to conclude that participants experienced no adverse events.
In general, a clinical result must be interpreted in relation to the population, outcome definition, follow-up, analysis, and uncertainty. Here, the endpoint definition and design are available, but the numerical randomized count and comparative outcome analyses are not reported in the registry record. The correct interpretation is therefore bounded: the record specifies what was intended to be counted, but it does not provide a numerical endpoint result or evidence for a treatment comparison. Neither absence of a reported result nor lack of a comparison should be treated as proof of no effect.
12. Why This Trial Matters Statistically
Statistically, DREAMM 5 illustrates the distinction between a platform’s broad treatment-evaluation purpose and the specific endpoint reported in a registry. The study is designed to evaluate belantamab mafodotin as monotherapy and in combinations through multiple sub-studies under a master protocol. Yet the listed primary endpoint is a count of participants randomized, not a clinical outcome that compares those treatment strategies.
That distinction matters when interpreting registry records. A trial can be randomized while a particular posted endpoint remains descriptive. The word “randomized” does not imply that every outcome shown is analyzed as a randomized comparison. For this endpoint, the record reports no analyses and notes fewer than two arms. As a result, it cannot support a comparative estimate, regardless of the number of treatment combinations named in the design.
The platform structure also makes clarity about populations and comparisons especially important. The overall enrollment is 208, while the primary endpoint population is those who passed screening and were randomized. A reader needs the actual randomized count and outcome-specific analysis populations to understand how much information contributed to each result. Those details are not reported in the registry record for this endpoint.
More broadly, the record demonstrates why endpoint definitions, numerical results, and analysis plans each have a distinct role. A clearly named endpoint indicates what should be measured; a reported result states what was observed; and an analysis plan explains how estimates and uncertainty are derived. For this primary outcome, the definition is present, but the numeric result and comparative analysis are not. This limits statistical interpretation without negating the study’s stated platform design or its overall enrollment.
13. 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 main limitation specific to the posted primary outcome is that the registry gives its definition but not its numerical result. The endpoint is the number of participants who passed screening and were randomized across sub-studies at Day 1. The overall enrollment of 208 is reported, but the record does not identify that figure as the endpoint count. The randomized count therefore cannot be recovered from the primary outcome entry.
The record lists zero analyses for the primary outcome and indicates fewer than two arms in that outcome. There is no reported arm-specific result, treatment contrast, confidence interval, or p-value for this endpoint. As a result, it cannot be used to assess the magnitude or precision of differences across the study’s monotherapy and combination cohorts.
The platform includes multiple dose-exploration and cohort-expansion groups, but the registry does not report the allocation details or sample sizes for each sub-study in the information. Nor does it report the statistical analysis plan, multiplicity procedures, interim-analysis methods, missing-data handling, or detailed analysis populations for clinical outcomes. These omissions prevent assessment of how comparative hypotheses were defined and how results would be interpreted across multiple sub-studies.
The safety fields list zero counts and zero at-risk values for the all-screened group. With no reported at-risk participants in those fields, they do not permit a meaningful estimate of adverse-event frequency or an inference about safety. These limitations concern what can be concluded from the registry record; they do not determine what may have been measured or analyzed outside the reported information.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) — NCT04126200.
- Registry record last updated 2026-05-06; status last verified 2026-04.
- Results first posted 2026-05-06.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
NCT04126200 is DREAMM 5, a randomized, open-label phase I/II platform study of belantamab mafodotin as monotherapy and in combinations for participants with relapsed/refractory multiple myeloma. The registry describes a master protocol with multiple dose-exploration sub-studies and cohort expansions. It lists overall enrollment as 208 and status as active, not recruiting.
The primary endpoint is the number of participants who passed screening and were randomized across sub-studies, with a Day 1 timeframe. Its numerical result is not reported in the registry record. The record lists no analyses for this endpoint and indicates fewer than two arms are available, so it provides no primary-endpoint treatment comparison.
The study start is listed as 2019-10-07, with primary completion on 2025-04-17. The record does not report the detailed statistical plan, multiplicity procedures, interim analyses, or missing-data methods. The posted primary outcome is therefore informative about the intended enrollment count, but not about comparative clinical effects.