A Phase 3 interventional study of Daratumumab and VELCADE (Bortezomib) in Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Completed at 105 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
This is an open-label (physicians and participants know the identity of the assigned treatment), randomized (the study medication is assigned by chance), multicenter, active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma. Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of prior treatment programs (1 vs. 2 or 3 vs. >3), and prior VELCADE treatment ("no" vs. "yes"). Within each stratum, participants will be randomized to one of the treatment groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 498 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daratumumab, VELCADE and dexamethasone
Drug: Daratumumab · Drug: VELCADE (Bortezomib) · Drug: Dexamethasone
VELCADE and dexamethasone.
Drug: VELCADE (Bortezomib) · Drug: Dexamethasone
Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.
VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.
Also known as: VELCADE
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.
Progression-free Survival (PFS)
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 following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (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/24hours; 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.
Time frame: From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)
Time to Disease Progression (TTP)
TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from 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/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (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 Plasma Cell (PC) proliferative disorder.
Time frame: From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)
Percentage of Participants With a Very Good Partial Response (VGPR) or Better
Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for 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, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 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.
Time frame: Up to disease progression (approximately 6 years 9 months)
Overall Response Rate (ORR)
The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for 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, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
Time frame: Up to disease progression (approximately 6 years 9 months)
Percentage of Participants With Negative Minimal Residual Disease (MRD)
The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
Time frame: Up to disease progression (approximately 6 years 9 months)
Overall Survival (OS)
Overall Survival was measured from the date of randomization to the date of the participant's death.
Time frame: Up to 6 years 9 months
| Milestone | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Started | 247 | 251 |
| Daratumumab monotherapy | 87 | 0 |
| Completed | 0 | 0 |
| Not completed | 247 | 251 |
| Withdrew: Death | 170 | 148 |
| Withdrew: Withdrawal by subject | 19 | 10 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Uspecified | 55 | 90 |
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 following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (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/24hours; 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.
| months | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Progression-free Survival (PFS) | 7.16 (6.21 to 7.85) | NA (12.25 to NA) |
TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from 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/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (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 Plasma Cell (PC) proliferative disorder.
| months | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Time to Disease Progression (TTP) | 7.29 (6.41 to 8.08) | NA (12.25 to NA) |
Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for 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, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 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.
| percentage of participants | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Percentage of Participants With a Very Good Partial Response (VGPR) or Better | 29.1 (23.3 to 35.3) | 59.2 (52.7 to 65.4) |
The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for 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, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
| percentage of participants | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Overall Response Rate (ORR) | 63.2 (56.7 to 69.4) | 82.9 (77.5 to 87.5) |
The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
| percentage of participants | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Percentage of Participants With Negative Minimal Residual Disease (MRD) | 2.8 | 13.5 |
Overall Survival was measured from the date of randomization to the date of the participant's death.
| months | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) |
|---|---|---|
| Overall Survival (OS) | 38.51 (31.18 to 46.23) | 49.58 (42.18 to 62.32) |
Collected over Up to 6 years 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bortezomib + Dexamethasone (Vd) | — | 81/237 (34.2%) | 217/237 (91.6%) |
| Daratumumab + Bortezomib and Dexamethasone (DVd) | — | 134/243 (55.1%) | 238/243 (97.9%) |
| Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy | — | 7/87 (8%) | 29/87 (33.3%) |
| Event | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy |
|---|---|---|---|
| PneumoniaInfections and infestations | 24/237 | 26/243 | 0/87 |
| AnaemiaBlood and lymphatic system disorders | 1/237 | 9/243 | 1/87 |
| PyrexiaGeneral disorders | 4/237 | 7/243 | 1/87 |
| BronchitisInfections and infestations | 2/237 | 7/243 | 0/87 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/237 | 6/243 | 1/87 |
| Atrial fibrillationCardiac disorders | 0/237 | 6/243 | 0/87 |
| Upper respiratory tract infectionInfections and infestations | 2/237 | 6/243 | 0/87 |
| DiarrhoeaGastrointestinal disorders | 0/237 | 4/243 | 0/87 |
| SepsisInfections and infestations | 2/237 | 4/243 | 0/87 |
| Bone painMusculoskeletal and connective tissue disorders | 1/237 | 4/243 | 0/87 |
| Event | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy |
|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 105/237 | 145/243 | 0/87 |
| Peripheral sensory neuropathyNervous system disorders | 90/237 | 122/243 | 0/87 |
| DiarrhoeaGastrointestinal disorders | 53/237 | 88/243 | 0/87 |
| Upper respiratory tract infectionInfections and infestations | 41/237 | 88/243 | 1/87 |
| AnaemiaBlood and lymphatic system disorders | 75/237 | 68/243 | 1/87 |
| CoughRespiratory, thoracic and mediastinal disorders | 30/237 | 71/243 | 3/87 |
| FatigueGeneral disorders | 58/237 | 57/243 | 0/87 |
| ConstipationGastrointestinal disorders | 37/237 | 56/243 | 0/87 |
| Back painMusculoskeletal and connective tissue disorders | 24/237 | 52/243 | 2/87 |
| Oedema peripheralGeneral disorders | 20/237 | 48/243 | 0/87 |
| Age, Continuous(years) | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Total |
|---|---|---|---|
| Mean | 63.9 ± 9.81 | 62.8 ± 9.66 | 63.4 ± 9.74 |
| Sex: Female, Male(Participants) | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Total |
|---|---|---|---|
| Female | 99 | 114 | 213 |
| Male | 148 | 137 | 285 |
| Region of Enrollment(participants) | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Total |
|---|---|---|---|
| Australia | 20 | 23 | 43 |
| Brazil | 9 | 13 | 22 |
| Czech Republic | 19 | 16 | 35 |
| Germany | 21 | 21 | 42 |
| Hungary | 14 | 16 | 30 |
| Italy | 25 | 24 | 49 |
| Korea, Republic of | 8 | 10 | 18 |
| Mexico | 1 | 2 | 3 |
| Netherlands | 14 | 11 | 25 |
| Poland | 18 | 16 | 34 |
| Russian Federation | 13 | 21 | 34 |
| Spain | 19 | 10 | 29 |
| Sweden | 9 | 10 | 19 |
| Turkey | 14 | 14 | 28 |
| Ukraine | 22 | 28 | 50 |
| United States | 21 | 16 | 37 |
| Stage of Disease (ISS)(participants) | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Total |
|---|---|---|---|
| I | 96 | 98 | 194 |
| II | 100 | 94 | 194 |
| III | 51 | 59 | 110 |
| No. of Prior Lines of Therapy(participants) | Bortezomib + Dexamethasone (Vd) | Daratumumab + Bortezomib and Dexamethasone (DVd) | Total |
|---|---|---|---|
| 1 | 113 | 122 | 235 |
| 2 | 74 | 70 | 144 |
| 3 | 32 | 37 | 69 |
| >3 | 28 | 22 | 50 |
Showing the first 100 of 105 sites across 15 countries. Choose a country and city above to see the rest.
Ran from Aug 2014 to primary completion in Jan 2016, 16 months.
Results were first posted in Feb 2017, 1 year after primary completion.
Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's 16 months is below that.
Counting every sponsor, half of 178 studies reached it within 56 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daratumumab
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