Trial · NCT02195479
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
NCT02195479, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2018-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma. Trials, record NCT02195479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195479
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02195479
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 706 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Velcade, Melphalan, Prednisone, Daratumumab IV, Dexamethasone, Daratumumab SC
- First posted
- 2014-07-21
- Last updated
- 2025-08-22
- Other registries' IDs
- eudract:2014-002272-88
- Results first posted
- 2018-12-17
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) up to 2.4 years | PFS: duration from date of randomization to progressive disease (PD)/death, 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 grams per deciliter \[g/dL\]); Urine M-component (absolute increase \>=200 milligrams \[mg\]/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow Plasma cells (PC) percentage (%) (absolute % \>=10%); Bone marrow PC%: absolute% \>10%; Definite development of new bone lesions/soft tissue plasmacytomas/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 | Overall Response Rate (ORR) | From randomization (Day -3) up to 2.4 years | The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (\>=) 50 percentage (%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>=90% or to \<200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required. |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 2.4 years | VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response\[sCR\]) 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 immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. |
| Secondary | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 2.4 years | CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (\<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. |
| Secondary | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 2.4 years | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells (PCs) in bone marrow. |
| Secondary | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 8.3 years | The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). |
| Secondary | Overall Survival (OS) | From randomization (Day -3) up to 8.3 years | Overall Survival (OS) was measured from the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. |
| Secondary | Progression Free Survival on Next Line of Therapy (PFS2) | From randomization (Day -3) up to 8.3 years | Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment. |
| Secondary | Time to Disease Progression (TTP) | From randomization (Day -3) up to 2.4 years | TTP: Time from date of randomization to date of first documented evidence of PD 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 \[mg/dL\]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % \>=10%); Bone marrow PC %: absolute % \>10%; 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 2.4 years | Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas was also required. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes18
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) up to 2.4 years | Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | From randomization (Day -3) up to 2.4 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Very Good Partial Response (VGPR) or Better | From randomization (Day -3) up to 2.4 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response (CR) or Better | From randomization (Day -3) up to 2.4 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stringent Complete Response (sCR) | From randomization (Day -3) up to 2.4 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Negative Minimal Residual Disease (MRD) | From randomization (Day -3) up to 8.3 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From randomization (Day -3) up to 8.3 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Progression Free Survival on Next Line of Therapy (PFS2) | From randomization (Day -3) up to 8.3 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Time to Disease Progression (TTP) | From randomization (Day -3) up to 2.4 years | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Time to Response | From randomization (Day -3) up to 2.4 years | Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint. | Months | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group118
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, Melphalan and Prednisone (VMP) | 18.14 | 95% Confidence Interval 16.53 to 19.91 | Months | |
| Progression Free Survival (PFS) | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Response Rate (ORR) | Velcade, Melphalan and Prednisone (VMP) | 73.9 | Percentage of participants | ||
| Overall Response Rate (ORR) | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 90.9 | Percentage of participants | ||
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | Velcade, Melphalan and Prednisone (VMP) | 49.7 | Percentage of participants | ||
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 71.1 | Percentage of participants | ||
| Percentage of Participants With Complete Response (CR) or Better | Velcade, Melphalan and Prednisone (VMP) | 24.4 | Percentage of participants | ||
| Percentage of Participants With Complete Response (CR) or Better | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 42.6 | Percentage of participants | ||
| Percentage of Participants With Stringent Complete Response (sCR) | Velcade, Melphalan and Prednisone (VMP) | 7.0 | Percentage of participants | ||
| Percentage of Participants With Stringent Complete Response (sCR) | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 18.0 | Percentage of participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Velcade, Melphalan and Prednisone (VMP) | 356 | |
| Overall Study | STARTED | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 350 | |
| Overall Study | Treated | Velcade, Melphalan and Prednisone (VMP) | 354 | |
| Overall Study | Treated | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 346 | |
| Overall Study | COMPLETED | Velcade, Melphalan and Prednisone (VMP) | 0 | |
| Overall Study | COMPLETED | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 0 | |
| Overall Study | NOT COMPLETED | Velcade, Melphalan and Prednisone (VMP) | 356 | |
| Overall Study | NOT COMPLETED | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 350 |
Source ClinicalTrials.gov
Adverse events620
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, Melphalan and Prednisone (VMP) | 129 | 354 | |
| other | Anaemia | Blood and lymphatic system disorders | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 110 | 346 | |
| other | Leukopenia | Blood and lymphatic system disorders | Velcade, Melphalan and Prednisone (VMP) | 53 | 354 | |
| other | Leukopenia | Blood and lymphatic system disorders | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 47 | 346 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Velcade, Melphalan and Prednisone (VMP) | 36 | 354 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 39 | 346 | |
| other | Neutropenia | Blood and lymphatic system disorders | Velcade, Melphalan and Prednisone (VMP) | 186 | 354 | |
| other | Neutropenia | Blood and lymphatic system disorders | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 174 | 346 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Velcade, Melphalan and Prednisone (VMP) | 189 | 354 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 172 | 346 |
1 to 10 of 620Source ClinicalTrials.gov
See all 620 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Velcade, Melphalan and Prednisone (VMP) | 217 | 356 |
| Total, all-cause mortality | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 172 | 350 |
| Total, other adverse events | Velcade, Melphalan and Prednisone (VMP) | 331 | 354 |
| Total, other adverse events | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 329 | 346 |
| Total, serious adverse events | Velcade, Melphalan and Prednisone (VMP) | 117 | 354 |
| Total, serious adverse events | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 186 | 346 |
Source ClinicalTrials.gov
Papers8
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 |
|---|---|
| Velcade, Melphalan and Prednisone (VMP) vs Daratumumab, Velcade, Melphalan and Prednisone (D-VMP): deaths from any cause | Trial comparisons |
| Velcade, Melphalan and Prednisone (VMP) vs Daratumumab, Velcade, Melphalan and Prednisone (D-VMP): 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/NCT02195479
GET https://conductscience.org/api/trials/v1/NCT02195479/results?page=2