Trial · NCT02252172
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
NCT02252172, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. Trials, record NCT02252172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02252172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02252172
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 737 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab IV, Lenalidomide, Dexamethasone, Daratumumab SC
- First posted
- 2014-09-30
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2014-002273-11
- Results first posted
- 2020-01-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) | PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \[\>=\] 0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder. |
| Secondary | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 6.6 years | Percentage of participants with a CR or better (CR or stringent complete response \[sCR\]) based on computerized algorithm as per IMWG criteria was reported. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (\<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio was required. sCR was defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence, 2-4 color flow cytometry (FC). |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 6.6 years | VGPR or better rate was defined as the percentage of participants who achieved VGPR or better (VGPR, CR or sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein level less than (\<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. |
| Secondary | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 6.6 years | MRD negativity rate is defined as the percentage of participants who had negative MRD at any time point after the date of randomization and prior to subsequent antimyeloma therapy. MRD was assessed in participants who achieved CR or better. |
| Secondary | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 6.6 years | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by IHC, immunofluorescence or 2- to 4-color FC. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; \<5% PCs in bone marrow. |
| Secondary | Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | ORR was the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required. VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and \< 5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. |
| Secondary | Overall Survival (OS) | From randomization (Day -3) up to 8.7 years | OS was measured from the date of randomization to the date of the death. Median OS was estimated by using the Kaplan-Meier method. |
| Secondary | Time to Disease Progression (TTP) | From randomization (Day -3) up to 6.6 years | TTP was defined as the time from the date of randomization to date of first documented evidence of PD or death due to PD, whichever occurred first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. |
| Secondary | Time to Response | From randomization (Day -3) up to 6.6 years | Time to first response, time to VGPR or better, time to CR or better and time to best response was reported for this endpoint. Time to response: time from date of randomization to first efficacy evaluation that met criteria for PR/better as their best response (PR, CR, or better) based on IMWG criteria. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of \>=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. Based on computerized algorithm, according to IMWG response criteria, VGPR or better: proportion of participants with a response of VGPR or better (i.e., VGPR, CR or sCR), CR or better: proportion of participants with a response of CR or better (i.e., CR or sCR). |
| Secondary | Duration of Response (DoR) | From randomization (Day -3) up to 6.6 years | DoR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years) | Intent-to-treat (ITT) population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 6.6 years | Intent-to-treat (ITT) population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization (Day -3) up to 8.7 years | ITT population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Time to Disease Progression (TTP) | From randomization (Day -3) up to 6.6 years | ITT population included all randomized participants. | Months | MEDIAN |
| SECONDARY | Time to Response | From randomization (Day -3) up to 6.6 years | Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints. | Months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | From randomization (Day -3) up to 6.6 years | Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (Overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Lenalidomide + Dexamethasone (Rd) | 31.87 | 95% Confidence Interval 28.94 to NA | Months | |
| Progression-free Survival (PFS) | Daratumumab + Lenalidomide + Dexamethasone (DRd) | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants With Complete Response (CR) or Better | Lenalidomide + Dexamethasone (Rd) | 30.1 | 95% Confidence Interval 25.4 to 35.0 | Percentage of participants | |
| Percentage of Participants With Complete Response (CR) or Better | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 51.1 | 95% Confidence Interval 45.9 to 56.3 | Percentage of participants | |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | Lenalidomide + Dexamethasone (Rd) | 56.9 | 95% Confidence Interval 51.7 to 62.0 | Percentage of participants | |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 81.5 | 95% Confidence Interval 77.2 to 85.4 | Percentage of participants | |
| Percentage of Participants With Negative Minimal Residual Disease (MRD) | Lenalidomide + Dexamethasone (Rd) | 11.1 | 95% Confidence Interval 8.1 to 14.8 | Percentage of participants | |
| Percentage of Participants With Negative Minimal Residual Disease (MRD) | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 32.1 | 95% Confidence Interval 27.3 to 37.1 | Percentage of participants | |
| Percentage of Participants With Stringent Complete Response (sCR) | Lenalidomide + Dexamethasone (Rd) | 15.7 | 95% Confidence Interval 12.2 to 19.8 | Percentage of participants | |
| Percentage of Participants With Stringent Complete Response (sCR) | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 35.6 | 95% Confidence Interval 30.7 to 40.7 | Percentage of participants |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide + Dexamethasone (Rd) | 369 | |
| Overall Study | STARTED | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 368 | |
| Overall Study | Treated | Lenalidomide + Dexamethasone (Rd) | 365 | |
| Overall Study | Treated | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 364 | |
| Overall Study | COMPLETED | Lenalidomide + Dexamethasone (Rd) | 0 | |
| Overall Study | COMPLETED | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 0 | |
| Overall Study | NOT COMPLETED | Lenalidomide + Dexamethasone (Rd) | 369 | |
| Overall Study | NOT COMPLETED | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 368 |
Source ClinicalTrials.gov
Adverse events1,208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lenalidomide + Dexamethasone (Rd) | 148 | 365 | |
| other | Anaemia | Blood and lymphatic system disorders | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 154 | 364 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lenalidomide + Dexamethasone (Rd) | 42 | 365 | |
| other | Leukopenia | Blood and lymphatic system disorders | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 73 | 364 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lenalidomide + Dexamethasone (Rd) | 48 | 365 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 72 | 364 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lenalidomide + Dexamethasone (Rd) | 167 | 365 | |
| other | Neutropenia | Blood and lymphatic system disorders | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 224 | 364 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lenalidomide + Dexamethasone (Rd) | 76 | 365 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 82 | 364 |
1 to 10 of 1,208Source ClinicalTrials.gov
See all 1,208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide + Dexamethasone (Rd) | 259 | 369 |
| Total, all-cause mortality | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 287 | 368 |
| Total, other adverse events | Lenalidomide + Dexamethasone (Rd) | 358 | 365 |
| Total, other adverse events | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 362 | 364 |
| Total, serious adverse events | Lenalidomide + Dexamethasone (Rd) | 262 | 365 |
| Total, serious adverse events | Daratumumab + Lenalidomide + Dexamethasone (DRd) | 289 | 364 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenalidomide + Dexamethasone (Rd) vs Daratumumab + Lenalidomide + Dexamethasone (DRd): deaths from any cause | Trial comparisons |
| Lenalidomide + Dexamethasone (Rd) vs Daratumumab + Lenalidomide + Dexamethasone (DRd): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02252172
GET https://conductscience.org/api/trials/v1/NCT02252172/results?page=2