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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02195479
Ethics application status
Date submitted
18/07/2014
Date registered
21/07/2014
Date last updated
9/12/2024

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 until the end of study. 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 until the end of study .

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 until the end of study. 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)
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)
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
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
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)
Timepoint [4] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [5] 0 0
Overall Survival (OS)
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)
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)
Timepoint [7] 0 0
From randomization to disease progression (up to 2.4 years)
Secondary outcome [8] 0 0
Time to Disease Progression (TTP)
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
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)
Timepoint [10] 0 0
Up to 2.4 years
Secondary outcome [11] 0 0
Time to Next Treatment (TNT)
Timepoint [11] 0 0
Approximately up to 2.4 years
Secondary outcome [12] 0 0
Percentage of Participants With Best M-protein Response
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
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)
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/08/2024
Sample size
Target
Accrual to date
Final
706
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
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Missouri
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United States of America
State/province [5] 0 0
Ohio
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United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
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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
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Belgium
State/province [13] 0 0
Brussel
Country [14] 0 0
Belgium
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Charleroi
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Belgium
State/province [15] 0 0
Gent
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Belgium
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Kortrijk
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Belgium
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Roeselare
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Belgium
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Turnhout
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Belgium
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Yvoir
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Brazil
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Barretos
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Brazil
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Cuiaba - Mount
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Brazil
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Fortaleza
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Brazil
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Goiania
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Brazil
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Natal
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
State/province [29] 0 0
Pleven
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Plovdiv
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Bulgaria
State/province [31] 0 0
Sofia
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Varna
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Bulgaria
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Vratsa
Country [34] 0 0
Croatia
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Zadar
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Croatia
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Zagreb
Country [36] 0 0
Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava-Poruba
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Czechia
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Praha 10
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Czechia
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Praha 2
Country [42] 0 0
Georgia
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Tbilisi
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Germany
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Berlin
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Germany
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Dortmund
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Germany
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Karlsruhe
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Germany
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Potsdam
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Germany
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Saarbrücken
Country [48] 0 0
Germany
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Stuttgart
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Germany
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Würzburg
Country [50] 0 0
Greece
State/province [50] 0 0
Athens Attica
Country [51] 0 0
Greece
State/province [51] 0 0
Athens
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Greece
State/province [52] 0 0
Patra
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Greece
State/province [53] 0 0
Thessaloniki
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Hungary
State/province [55] 0 0
Debrecen
Country [56] 0 0
Hungary
State/province [56] 0 0
Kaposvar
Country [57] 0 0
Hungary
State/province [57] 0 0
Pecs N/a
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Japan
State/province [58] 0 0
Chiba
Country [59] 0 0
Japan
State/province [59] 0 0
Hitachi
Country [60] 0 0
Japan
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Kanazawa
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Japan
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Kawasaki
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Japan
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Kobe
Country [63] 0 0
Japan
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Kurume
Country [64] 0 0
Japan
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Matsuyama
Country [65] 0 0
Japan
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Nagoya
Country [66] 0 0
Japan
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Narita
Country [67] 0 0
Japan
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Ohgaki
Country [68] 0 0
Japan
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Okayama
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
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Japan
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Sendai-shi
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Japan
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Shibukawa
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Japan
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Shibuya
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Japan
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Tachikawa
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Japan
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Toyohashi
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Hwasun
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Incheon
Country [79] 0 0
Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
Country [81] 0 0
North Macedonia
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Skopje
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Gdansk
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Poland
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Legnica
Country [87] 0 0
Poland
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Lublin
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Poland
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Opole
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Poland
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Slupsk
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Poland
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Warszawa Ul
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Iasi
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Russian Federation
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Arkhangelsk
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Russian Federation
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Dzerzhinsk
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Russian Federation
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Ekaterinbourg
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Sochi
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Russian Federation
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St Petersburg
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Russian Federation
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Volgograd
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Serbia
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Sremska Kamenica
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Serbia
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Zemun
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Spain
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Andalucía
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Girona
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Spain
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La Laguna
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Spain
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Madrid
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Spain
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Maranon
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Spain
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Murcia N/a
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Spain
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Ourense
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Spain
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Zaragoza
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Turkey
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Altindag
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Turkey
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Ankara
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Turkey
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Aydin
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Samsun
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Turkey
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Tekirdag
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Ukraine
State/province [137] 0 0
Cherkassy
Country [138] 0 0
Ukraine
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Dnepropetrovsk
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Ukraine
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Ivano-Frankivsk
Country [140] 0 0
Ukraine
State/province [140] 0 0
Kharkov
Country [141] 0 0
Ukraine
State/province [141] 0 0
Khmelnitskiy
Country [142] 0 0
Ukraine
State/province [142] 0 0
Lviv
Country [143] 0 0
Ukraine
State/province [143] 0 0
Zaporizhzhia
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Birmingham
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Cambridge
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Colchester
Country [147] 0 0
United Kingdom
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Harlow
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Leicester
Country [149] 0 0
United Kingdom
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London
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Manchester
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Woolwich

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02195479