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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

Primary Purpose

Multiple Myeloma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Velcade

Melphalan

Prednisone

Daratumumab IV

Dexamethasone

Daratumumab SC

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Bortezomib, Velcade, Melphalan, Prednisone, Daratumumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment Arm A (VMP Alone)

Treatment Arm B (D-VMP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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).

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.

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.

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.

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.

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%.

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.

Time to Next Treatment (TNT)

Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

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).

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.

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)

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.

Full Information

NCT ID

NCT02195479

First Posted

July 18, 2014

Last Updated

October 10, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02195479

Brief 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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 9, 2014 (Actual)

Primary Completion Date

November 21, 2017 (Actual)

Study Completion Date

February 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Treatment phase will include 2 treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone and Treatment B: participants will receive daratumumab in combination with VMP).Two interim analyses are planned. The first will be to evaluate safety after a total of approximately 100 participants have been treated for at least 2 cycles or discontinued the study treatment. The second will be to evaluate cumulative interim safety and efficacy data, and will be performed when approximately 216 PFS events have been accumulated. The final OS analysis will occur when approximately 382 deaths have occurred. Efficacy will be primarily measured by comparison of PFS between the two treatment arms. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, Bortezomib, Velcade, Melphalan, Prednisone, Daratumumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

706 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm A (VMP Alone)

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment Arm B (D-VMP)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Velcade

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Melphalan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Daratumumab IV

Intervention Description

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 .

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Daratumumab SC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From randomization to either disease progression or death whichever occurs first (up to 2.4 years)

Secondary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

Time Frame

From randomization to disease progression (up to 2.4 years)

Title

Percentage of Participants With Very Good Partial Response (VGPR) or Better

Description

Time Frame

From randomization to disease progression (up to 2.4 years)

Title

Percentage of Participants With Complete Response (CR) or Better

Description

Time Frame

From randomization to disease progression (up to 2.4 years)

Title

Percentage of Participants With Negative Minimal Residual Disease (MRD)

Description

Time Frame

From randomization to disease progression (up to 2.4 years)

Title

Overall Survival (OS)

Description

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.

Time Frame

From randomization to death (up to approximately 2.4 years)

Title

Progression Free Survival on Next Line of Therapy (PFS2)

Description

Time Frame

From randomization to either disease progression or death whichever occurs first (up to 2.4 years)

Title

Percentage of Participants With Stringent Complete Response (sCR)

Description

Time Frame

From randomization to disease progression (up to 2.4 years)

Title

Time to Disease Progression (TTP)

Description

Time Frame

From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)

Title

Time to Response

Description

Time Frame

From randomization to first documented PR or better (up to 2.4 years)

Title

Duration of Response (DOR)

Description

Time Frame

Up to 2.4 years

Title

Time to Next Treatment (TNT)

Description

Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

Time Frame

Approximately up to 2.4 years

Title

Percentage of Participants With Best M-protein Response

Description

Time Frame

Approximately up to 2.4 years

Title

Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score

Description

Time Frame

Baseline, Months 3, 6, 9, 12 and 18

Title

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)

Description

Time Frame

Baseline, Months 3, 6, 9, 12 and 18

Title

Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score

Description

Time Frame

Baseline, Months 3, 6, 9, 12 and 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

California City

State/Province

California

Country

United States

City

Corona

State/Province

California

Country

United States

City

Fountain Valley

State/Province

California

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United States

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Los Angeles

State/Province

California

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United States

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Hialeah

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Florida

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United States

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Orange Park

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Florida

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United States

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Chicago

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Illinois

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United States

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Springfield

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Missouri

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United States

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Cleveland

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Ohio

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United States

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Fredericksburg

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Virginia

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United States

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Buenos Aires

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Argentina

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Ciudad Autonoma Buenos Aires

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Argentina

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Córdoba

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Argentina

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Santa Fe

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Argentina

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Adelaide

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Australia

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Bendigo

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Australia

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Camperdown N/a

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Australia

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Geelong

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Australia

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Gosford

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Australia

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Greenslopes

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Australia

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Hobart

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Australia

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North Adelaide

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Australia

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Parkville

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Australia

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Antwerpen

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Belgium

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Antwerp

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Belgium

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Brussel

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Belgium

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Charleroi

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Belgium

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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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Belgium

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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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Brazil

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São Paulo

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Brazil

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Pleven

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Bulgaria

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Plovdiv

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Bulgaria

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Sofia

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Bulgaria

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Varna

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Bulgaria

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Vratsa

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Bulgaria

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Zadar

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Croatia

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Zagreb

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Croatia

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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

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Czechia

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Tbilisi

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Georgia

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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

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Germany

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Stuttgart

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Germany

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Würzburg

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Germany

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Athens Attica

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Greece

City

Athens

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Greece

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Patra

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Greece

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Thessaloniki

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Greece

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Budapest

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Hungary

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Debrecen

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Hungary

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Kaposvar

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Hungary

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Pecs N/a

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Hungary

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Chiba

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Japan

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Hitachi

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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

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Japan

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Kurume

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Japan

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Matsuyama

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Japan

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Nagoya

Country

Japan

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Narita

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Japan

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Ohgaki

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Japan

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Okayama

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Japan

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Osaka

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Japan

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Sendai-shi

Country

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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Japan

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Busan

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Korea, Republic of

City

Gyeonggi-do

Country

Korea, Republic of

City

Hwasun

Country

Korea, Republic of

City

Incheon

Country

Korea, Republic of

City

Seongnam

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Skopje

Country

North Macedonia

City

Bialystok

Country

Poland

City

Bydgoszcz

Country

Poland

City

Chorzow

Country

Poland

City

Gdansk

Country

Poland

City

Legnica

Country

Poland

City

Lublin

Country

Poland

City

Opole

Country

Poland

City

Slupsk

Country

Poland

City

Warszawa Ul

Country

Poland

City

Warszawa

Country

Poland

City

Wroclaw

Country

Poland

City

Lisboa

Country

Portugal

City

Lisbon

Country

Portugal

City

Porto

Country

Portugal

City

Brasov

Country

Romania

City

Bucharest

Country

Romania

City

Iasi

Country

Romania

City

Arkhangelsk

Country

Russian Federation

City

Dzerzhinsk

Country

Russian Federation

City

Ekaterinbourg

Country

Russian Federation

City

Nizhny Novgorod

Country

Russian Federation

City

Ryazan

Country

Russian Federation

City

Saint-Petersburg

Country

Russian Federation

City

Saratov

Country

Russian Federation

City

Sochi

Country

Russian Federation

City

St Petersburg

Country

Russian Federation

City

Volgograd

Country

Russian Federation

City

Belgrade

Country

Serbia

City

Nis

Country

Serbia

City

Novi Sad

Country

Serbia

City

Sremska Kamenica

Country

Serbia

City

Zemun

Country

Serbia

City

Andalucía

Country

Spain

City

Badalona

Country

Spain

City

Barcelona

Country

Spain

City

Córdoba

Country

Spain

City

Girona

Country

Spain

City

La Laguna

Country

Spain

City

Madrid

Country

Spain

City

Maranon

Country

Spain

City

Murcia N/a

Country

Spain

City

Ourense

Country

Spain

City

Pamplona

Country

Spain

City

Salamanca

Country

Spain

City

Sevilla

Country

Spain

City

Toledo

Country

Spain

City

Valencia

Country

Spain

City

Zaragoza

Country

Spain

City

Altindag

Country

Turkey

City

Ankara

Country

Turkey

City

Aydin

Country

Turkey

City

Izmir

Country

Turkey

City

Kayseri

Country

Turkey

City

Samsun

Country

Turkey

City

Tekirdag

Country

Turkey

City

Cherkassy

Country

Ukraine

City

Dnepropetrovsk

Country

Ukraine

City

Ivano-Frankivsk

Country

Ukraine

City

Kharkov

Country

Ukraine

City

Khmelnitskiy

Country

Ukraine

City

Lviv

Country

Ukraine

City

Zaporizhzhia

Country

Ukraine

City

Birmingham

Country

United Kingdom

City

Cambridge

Country

United Kingdom

City

Colchester

Country

United Kingdom

City

Harlow

Country

United Kingdom

City

Leicester

Country

United Kingdom

City

London

Country

United Kingdom

City

Manchester

Country

United Kingdom

City

Woolwich

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34344638

Citation

Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Iida S, Blade J, Ukropec J, Pei H, Van Rampelbergh R, Kudva A, Qi M, San-Miguel J. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):785-798. doi: 10.1016/j.clml.2021.06.005. Epub 2021 Jun 18.

Results Reference

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PubMed Identifier

34289038

Citation

Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

Results Reference

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PubMed Identifier

34269818

Citation

San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439.

Results Reference

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PubMed Identifier

34078314

Citation

Knop S, Mateos MV, Dimopoulos MA, Suzuki K, Jakubowiak A, Doyen C, Lucio P, Nagy Z, Usenko G, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Losava G, Fujisaki T, Garg M, Wang J, Wroblewski S, Kudva A, Gries KS, Fastenau J, San-Miguel J, Cavo M. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial. BMC Cancer. 2021 Jun 2;21(1):659. doi: 10.1186/s12885-021-08325-2.

Results Reference

derived

PubMed Identifier

31836199

Citation

Mateos MV, Cavo M, Blade J, Dimopoulos MA, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Krevvata M, Chen Y, Wang J, Kudva A, Ukropec J, Wroblewski S, Qi M, Kobos R, San-Miguel J. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020 Jan 11;395(10218):132-141. doi: 10.1016/S0140-6736(19)32956-3. Epub 2019 Dec 10.

Results Reference

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PubMed Identifier

29231133

Citation

Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Kaplan P, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Chiu C, Wang J, Carson R, Crist W, Deraedt W, Nguyen H, Qi M, San-Miguel J; ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12.

Results Reference

derived

Learn more about this trial

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

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