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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02195479
• Date of registration: 18/07/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• 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
• Date of first enrolment: December 9, 2014
• Target sample size: 706
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02195479
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, Czechia, Georgia, Germany, Greece, Hungary, Japan, Korea, Republic of, Macedonia, The Former Yugoslav Republic of, North Macedonia, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Velcade

Drug: Daratumumab IV

Drug: Daratumumab SC

Drug: Melphalan

Drug: Dexamethasone

Drug: Prednisone

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)]

Secondary Outcome(s)

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS) [Time Frame: Baseline, Months 3, 6, 9, 12 and 18]

Overall Response Rate (ORR) [Time Frame: From randomization to disease progression (up to 2.4 years)]

Percentage of Participants With Negative Minimal Residual Disease (MRD) [Time Frame: From randomization to disease progression (up to 2.4 years)]

Duration of Response (DOR) [Time Frame: Up to 2.4 years]

Percentage of Participants With Complete Response (CR) or Better [Time Frame: From randomization to disease progression (up to 2.4 years)]

Progression Free Survival on Next Line of Therapy (PFS2) [Time Frame: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)]

Time to Disease Progression (TTP) [Time Frame: From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)]

Overall Survival (OS) [Time Frame: From randomization to death (up to approximately 2.4 years)]

Time to Response [Time Frame: From randomization to first documented PR or better (up to 2.4 years)]

Percentage of Participants With Very Good Partial Response (VGPR) or Better [Time Frame: From randomization to disease progression (up to 2.4 years)]

Time to Next Treatment (TNT) [Time Frame: Approximately up to 2.4 years]

Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score [Time Frame: Baseline, Months 3, 6, 9, 12 and 18]

Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score [Time Frame: Baseline, Months 3, 6, 9, 12 and 18]

Percentage of Participants With Best M-protein Response [Time Frame: Approximately up to 2.4 years]

Percentage of Participants With Stringent Complete Response (sCR) [Time Frame: From randomization to disease progression (up to 2.4 years)]

Secondary ID(s)

2014-002272-88

CR104761

54767414MMY3007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02195479