Trial · NCT03710603
Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma
NCT03710603, Phase 3, Active not recruiting, Stichting European Myeloma Network; results first posted 2024-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma. Trials, record NCT03710603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03710603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma
- NCT number
- NCT03710603
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 709 participants, actual
- Lead sponsor
- Stichting European Myeloma Network
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab, Velcade, Lenalidomide, dexamethasone
- First posted
- 2018-10-18
- Last updated
- 2026-02-10
- Results first posted
- 2024-12-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months. | PFS was defined as duration from date of randomization to either progressive disease (PD)/death whichever occurred first. PD was defined as meeting any one of the following criteria: Increase of \>= 25 % in level of serum M-protein form lowest response value and absolute increase must be \>= 0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24 hours; Only in participants without measurable serum and urine M-protein levels; increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \> 10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder. |
| Secondary | Overall MRD Negativity Rate | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months. | Overall MRD-negativity rate was defined as the percentage of participants in the ITT population who achieved both MRD-negativity by NGS (at or below a sensitivity threshold of 10-5) in bone marrow aspirate and a CR or better response at any time after the date of randomization (and prior to disease progression, receipt of subsequent therapy, or both). |
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response \[VGPR\], CR or sCR) based on computerized algorithm as per IMWG 2011 criteria. PR -greater than or equal to (\>=) 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 are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required. A \>=50% reduction in the size of soft tissue plasmacytomas is 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, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry. |
| Secondary | Percentage of Participants With Overall Complete Response (CR) or Better | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG 2011 criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas (PCs), and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry. |
| Secondary | Progression-free Survival on the Next Line of Therapy (PFS2) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first. |
| Secondary | Overall Survival (OS) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Overall Survival (OS), measured from the date of from randomization to the date the subject's death |
| Secondary | Time to Response | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Time to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR) |
| Secondary | Duration of Response | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Duration of response (PR or better), duration of CR, duration of sCR, and duration of MRD-negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, whichever occurs first. |
| Secondary | Pharmacokinetic Concentrations of Daratumumab | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Pharmacokinetic concentrations of daratumumab |
| Secondary | Determine the Incidence of Anti-daratumumab Antibodies (Immunogenicity) for All Subjects Who Receive at Least 1 Dose of Daratumumab and Determine the Incidence of Anti-rHuPH20 Antibodies | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | Immunogenicity of daratumumab serum samples will be screened for antibodies binding to daratumumab and serum titer will also be determined from confirmed positive samples using validated immunoassay methods. Other immunogenicity analyses (eg, assessment of neutralizing capabilities) may be performed to further characterize the immune responses that are generated. Plasma samples will be screened for antibodies binding to rHuPH20 and will be assessed in confirmatory and titer assays as necessary |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months. | Randomized population, intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall MRD Negativity Rate | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months. | Randomized population, intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Overall Response Rate (ORR) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | The intent-to-treat (ITT) population included all randomized participants | percentage of participants with response | NUMBER |
| SECONDARY | Percentage of Participants With Overall Complete Response (CR) or Better | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | The intent-to-treat (ITT) population included all randomized participants | percentage of participants with response | NUMBER |
| SECONDARY | Progression-free Survival on the Next Line of Therapy (PFS2) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | |||
| SECONDARY | Overall Survival (OS) | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | |||
| SECONDARY | Time to Response | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | |||
| SECONDARY | Duration of Response | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | |||
| SECONDARY | Pharmacokinetic Concentrations of Daratumumab | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months | |||
| SECONDARY | Determine the Incidence of Anti-daratumumab Antibodies (Immunogenicity) for All Subjects Who Receive at Least 1 Dose of Daratumumab and Determine the Incidence of Anti-rHuPH20 Antibodies | From randomization to the clinical cutoff date. Maximum follow up was 54.41 months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group8
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) | Velcade Lenalidomide Dexamethasone (VRd) | 103 | Participants | ||
| Progression Free Survival (PFS) | Daratumumab + VRd (D-VRd) | 50 | Participants | ||
| Overall MRD Negativity Rate | Velcade Lenalidomide Dexamethasone (VRd) | 168 | Participants | ||
| Overall MRD Negativity Rate | Daratumumab + VRd (D-VRd) | 267 | Participants | ||
| Percentage of Participants With Overall Response Rate (ORR) | Velcade Lenalidomide Dexamethasone (VRd) | 93.8 | 95% Confidence Interval 90.7 to 96.1 | percentage of participants with response | |
| Percentage of Participants With Overall Response Rate (ORR) | Daratumumab + VRd (D-VRd) | 96.6 | 95% Confidence Interval 94.2 to 98.2 | percentage of participants with response | |
| Percentage of Participants With Overall Complete Response (CR) or Better | Velcade Lenalidomide Dexamethasone (VRd) | 70.1 | 95% Confidence Interval 65.0 to 74.8 | percentage of participants with response | |
| Percentage of Participants With Overall Complete Response (CR) or Better | Daratumumab + VRd (D-VRd) | 87.9 | 95% Confidence Interval 84.0 to 91.1 | percentage of participants with response |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Velcade Lenalidomide Dexamethasone (VRd) | 354 | |
| Overall Study | STARTED | Daratumumab + VRd (D-VRd) | 355 | |
| Overall Study | COMPLETED | Velcade Lenalidomide Dexamethasone (VRd) | 295 | |
| Overall Study | COMPLETED | Daratumumab + VRd (D-VRd) | 306 | |
| Overall Study | NOT COMPLETED | Velcade Lenalidomide Dexamethasone (VRd) | 59 | |
| Overall Study | NOT COMPLETED | Daratumumab + VRd (D-VRd) | 49 |
Source ClinicalTrials.gov
Adverse events728
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 | Velcade Lenalidomide Dexamethasone (VRd) | 72 | 347 | |
| other | Anaemia | Blood and lymphatic system disorders | Daratumumab + VRd (D-VRd) | 77 | 351 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Velcade Lenalidomide Dexamethasone (VRd) | 22 | 347 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Daratumumab + VRd (D-VRd) | 19 | 351 | |
| other | Leukopenia | Blood and lymphatic system disorders | Velcade Lenalidomide Dexamethasone (VRd) | 14 | 347 | |
| other | Leukopenia | Blood and lymphatic system disorders | Daratumumab + VRd (D-VRd) | 31 | 351 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Velcade Lenalidomide Dexamethasone (VRd) | 9 | 347 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Daratumumab + VRd (D-VRd) | 20 | 351 | |
| other | Neutropenia | Blood and lymphatic system disorders | Velcade Lenalidomide Dexamethasone (VRd) | 204 | 347 | |
| other | Neutropenia | Blood and lymphatic system disorders | Daratumumab + VRd (D-VRd) | 241 | 351 |
1 to 10 of 728Source ClinicalTrials.gov
See all 728 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Velcade Lenalidomide Dexamethasone (VRd) | 44 | 354 |
| Total, all-cause mortality | Daratumumab + VRd (D-VRd) | 34 | 355 |
| Total, other adverse events | Velcade Lenalidomide Dexamethasone (VRd) | 341 | 347 |
| Total, other adverse events | Daratumumab + VRd (D-VRd) | 348 | 351 |
| Total, serious adverse events | Velcade Lenalidomide Dexamethasone (VRd) | 171 | 347 |
| Total, serious adverse events | Daratumumab + VRd (D-VRd) | 200 | 351 |
Source ClinicalTrials.gov
Papers4
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Velcade Lenalidomide Dexamethasone (VRd) vs Daratumumab + VRd (D-VRd): Progression Free Survival (PFS) | Trial comparisons |
| Velcade Lenalidomide Dexamethasone (VRd) vs Daratumumab + VRd (D-VRd): deaths from any cause | Trial comparisons |
| Velcade Lenalidomide Dexamethasone (VRd) vs Daratumumab + VRd (D-VRd): Overall MRD Negativity Rate | Trial comparisons |
| Velcade Lenalidomide Dexamethasone (VRd) vs Daratumumab + VRd (D-VRd): 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/NCT03710603
GET https://conductscience.org/api/trials/v1/NCT03710603/events?page=2