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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02195479




Registration number
NCT02195479
Ethics application status
Date submitted
18/07/2014
Date registered
21/07/2014
Date last updated
25/08/2020

Titles & IDs
Public 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
Scientific title
A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy
Secondary ID [1] 0 0
54767414MMY3007
Secondary ID [2] 0 0
CR104761
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Velcade
Treatment: Drugs - Melphalan
Treatment: Drugs - Prednisone
Treatment: Drugs - Daratumumab IV
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab SC

Active Comparator: Treatment Arm A (VMP Alone) - Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.

Experimental: Treatment Arm B (D-VMP) - Participants will receive velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.


Treatment: Drugs: Velcade
Participants will receive velcade 1.3 mg/m^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9.

Treatment: Drugs: Melphalan
Participants will receive melphalan 9 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.

Treatment: Drugs: Prednisone
Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.

Treatment: Drugs: Daratumumab IV
Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end.

Treatment: Drugs: Dexamethasone
Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute.

Treatment: Drugs: Daratumumab SC
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) - 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 and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); 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) %(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.
Timepoint [1] 0 0
From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Secondary outcome [1] 0 0
Overall Response Rate (ORR) - 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 is also required.
Timepoint [1] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [2] 0 0
Percentage of Participants With Very Good Partial Response (VGPR) or Better - 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.
Timepoint [2] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [3] 0 0
Percentage of Participants With Complete Response (CR) or Better - 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.
Timepoint [3] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [4] 0 0
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 (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).
Timepoint [4] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [5] 0 0
Overall Survival (OS) - Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Timepoint [5] 0 0
From randomization to death (up to approximately 2.4 years)
Secondary outcome [6] 0 0
Progression Free Survival on Next Line of Therapy (PFS2) - 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.
Timepoint [6] 0 0
From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Secondary outcome [7] 0 0
Percentage of Participants With Stringent Complete Response (sCR) - 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.
Timepoint [7] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [8] 0 0
Time to Disease Progression (TTP) - 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 and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); 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.
Timepoint [8] 0 0
From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)
Secondary outcome [9] 0 0
Time to Response - 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%.
Timepoint [9] 0 0
From randomization to first documented PR or better (up to 2.4 years)
Secondary outcome [10] 0 0
Duration of Response (DOR) - DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Timepoint [10] 0 0
Up to 2.4 years
Secondary outcome [11] 0 0
Time to Next Treatment (TNT) - Time to next treatment is defined as the time from randomization to the start of the next-line treatment.
Timepoint [11] 0 0
Approximately up to 2.4 years
Secondary outcome [12] 0 0
Percentage of Participants With Best M-protein Response - Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).
Timepoint [12] 0 0
Approximately up to 2.4 years
Secondary outcome [13] 0 0
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score - The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.
Timepoint [13] 0 0
Baseline, Months 3, 6, 9, 12 and 18
Secondary outcome [14] 0 0
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS) - EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Timepoint [14] 0 0
Baseline, Months 3, 6, 9, 12 and 18
Secondary outcome [15] 0 0
Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score - EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.
Timepoint [15] 0 0
Baseline, Months 3, 6, 9, 12 and 18

Eligibility
Key inclusion criteria
- Participant must have documented multiple myeloma satisfying the calcium elevation,
renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria,
monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or
presence of a biopsy proven plasmacytoma, and measurable secretory disease, as
assessed by the central laboratory, and defined in protocol

- Participants who are newly diagnosed and not considered candidate for high-dose
chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in
participants <65 years: presence of important comorbid conditions likely to have a
negative impact on tolerability of high dose chemotherapy with stem cell
transplantation

- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0, 1, or 2

- Meet the clinical laboratory criteria as specified in the protocol

- A woman of childbearing potential must have a negative serum pregnancy test at
screening within 14 days prior to randomization

- Women of childbearing potential must commit to either abstain continuously from
heterosexual sexual intercourse or to use 2 methods of reliable birth control
simultaneously. This includes one highly effective form of contraception (tubal
ligation, intrauterine device, hormonal [birth control pills, injections, hormonal
patches, vaginal rings or implants] or partner's vasectomy) and one additional
effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical
cap). Contraception must begin prior to dosing. Reliable contraception is indicated
even where there has been a history of infertility, unless due to hysterectomy or
bilateral oophorectomy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of
undetermined significance, or smoldering multiple myeloma

- Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM
M-protein is present in the absence of a clonal plasma cell infiltration with lytic
bone lesions

- Participant has prior or current systemic therapy or SCT for multiple myeloma, with
the exception of an emergency use of a short course (equivalent of dexamethasone 40
mg/day for 4 days) of corticosteroids before treatment

- Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as
defined by the national cancer institute common terminology criteria for adverse
events (NCI CTCAE) Version 4

- Participant has a history of malignancy (other than multiple myeloma) within 3 years
before the date of randomization (exceptions are squamous and basal cell carcinomas of
the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the
investigator, with concurrence with the sponsor's medical monitor, is considered cured
with minimal risk of recurrence within 3 years)

- Participant has had radiation therapy within 14 days of randomization

- Participant has had plasmapheresis within 28 days of randomization

- Participant has known chronic obstructive pulmonary disease (COPD) (defined as a
forced expiratory volume in 1 second [FEV1] <50% of predicted normal), known moderate
or severe persistent asthma within the last 2 years or currently has uncontrolled
asthma of any classification (controlled intermittent asthma or controlled mild
persistent asthma is allowed)

- Participants with known or suspected COPD must have a FEV1 test during screening

- Participant is known to be seropositive for human immunodeficiency virus (HIV), known
to have hepatitis B surface antigen positivity, or history of to have a history of
hepatitis C

- Participant has any concurrent medical or psychiatric condition or disease (example
active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary
disease) that is likely to interfere with the study procedures or results, or that in
the opinion of the investigator, would constitute a hazard for participating in this
study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bendigo
Recruitment hospital [3] 0 0
- Camperdown N/a
Recruitment hospital [4] 0 0
- Geelong
Recruitment hospital [5] 0 0
- Gosford
Recruitment hospital [6] 0 0
- Greenslopes
Recruitment hospital [7] 0 0
- Hobart
Recruitment hospital [8] 0 0
- North Adelaide
Recruitment hospital [9] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bendigo
Recruitment postcode(s) [3] 0 0
- Camperdown N/a
Recruitment postcode(s) [4] 0 0
- Geelong
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Greenslopes
Recruitment postcode(s) [7] 0 0
- Hobart
Recruitment postcode(s) [8] 0 0
- North Adelaide
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autonoma Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Córdoba
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerpen
Country [12] 0 0
Belgium
State/province [12] 0 0
Antwerp
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussel
Country [14] 0 0
Belgium
State/province [14] 0 0
Charleroi
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Roeselare
Country [18] 0 0
Belgium
State/province [18] 0 0
Turnhout
Country [19] 0 0
Belgium
State/province [19] 0 0
Yvoir
Country [20] 0 0
Brazil
State/province [20] 0 0
Barretos
Country [21] 0 0
Brazil
State/province [21] 0 0
Cuiaba - Mount
Country [22] 0 0
Brazil
State/province [22] 0 0
Fortaleza Ceara
Country [23] 0 0
Brazil
State/province [23] 0 0
Fortaleza
Country [24] 0 0
Brazil
State/province [24] 0 0
Goiânia
Country [25] 0 0
Brazil
State/province [25] 0 0
Natal
Country [26] 0 0
Brazil
State/province [26] 0 0
Niteroi N/a
Country [27] 0 0
Brazil
State/province [27] 0 0
Porto Alegre
Country [28] 0 0
Brazil
State/province [28] 0 0
Riberao Preto
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Pleven
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Vratsa
Country [35] 0 0
Croatia
State/province [35] 0 0
Zadar
Country [36] 0 0
Croatia
State/province [36] 0 0
Zagreb
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Hradec Kralove
Country [39] 0 0
Czechia
State/province [39] 0 0
Olomouc
Country [40] 0 0
Czechia
State/province [40] 0 0
Ostrava-Poruba
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 10
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 2
Country [43] 0 0
Georgia
State/province [43] 0 0
Tbilisi
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Dortmund
Country [46] 0 0
Germany
State/province [46] 0 0
Karlsruhe
Country [47] 0 0
Germany
State/province [47] 0 0
Potsdam
Country [48] 0 0
Germany
State/province [48] 0 0
Saarbrücken
Country [49] 0 0
Germany
State/province [49] 0 0
Stuttgart
Country [50] 0 0
Germany
State/province [50] 0 0
Würzburg
Country [51] 0 0
Greece
State/province [51] 0 0
Athens Attica
Country [52] 0 0
Greece
State/province [52] 0 0
Athens
Country [53] 0 0
Greece
State/province [53] 0 0
Patra
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Hungary
State/province [57] 0 0
Kaposvar
Country [58] 0 0
Hungary
State/province [58] 0 0
Pecs N/a
Country [59] 0 0
Japan
State/province [59] 0 0
Chiba
Country [60] 0 0
Japan
State/province [60] 0 0
Hitachi
Country [61] 0 0
Japan
State/province [61] 0 0
Kanazawa
Country [62] 0 0
Japan
State/province [62] 0 0
Kawasaki
Country [63] 0 0
Japan
State/province [63] 0 0
Kobe
Country [64] 0 0
Japan
State/province [64] 0 0
Kurume
Country [65] 0 0
Japan
State/province [65] 0 0
Matsuyama
Country [66] 0 0
Japan
State/province [66] 0 0
Nagoya
Country [67] 0 0
Japan
State/province [67] 0 0
Narita
Country [68] 0 0
Japan
State/province [68] 0 0
Ohgaki
Country [69] 0 0
Japan
State/province [69] 0 0
Okayama
Country [70] 0 0
Japan
State/province [70] 0 0
Osaka
Country [71] 0 0
Japan
State/province [71] 0 0
Sendai
Country [72] 0 0
Japan
State/province [72] 0 0
Shibukawa
Country [73] 0 0
Japan
State/province [73] 0 0
Tachikawa
Country [74] 0 0
Japan
State/province [74] 0 0
Tokyo
Country [75] 0 0
Japan
State/province [75] 0 0
Toyohashi
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Busan
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Gyeonggi-do
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Incheon
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Jeonnam
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seongnam
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Seoul
Country [82] 0 0
North Macedonia
State/province [82] 0 0
Skopje
Country [83] 0 0
Poland
State/province [83] 0 0
Bialystok
Country [84] 0 0
Poland
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Woolwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if the addition of daratumumab to velcade
(bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared
with VMP alone in participants with previously untreated multiple myeloma who are ineligible
for high dose chemotherapy and autologous stem cell transplant (ASCT).
Trial website
https://clinicaltrials.gov/show/NCT02195479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications