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Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Daratumumab IV

Lenalidomide

Dexamethasone

Daratumumab SC

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Daratumumab, JNJ-54767414, Lenalidomide, Dexamethasone

Eligibility Criteria

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

Inclusion Criteria:

Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization
Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab
Man, who is sexually active with a woman of child-bearing potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab

Exclusion Criteria:

Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
Participant has a diagnosis of Waldenström'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 a history of malignancy (other than multiple myeloma) within 5 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 5 years)
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 had radiation therapy within 14 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), persistent asthma, or a history of asthma within the last 2 years (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) or hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid [RNA] quantitation positive)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lenalidomide and Dexamethasone (Rd)

Daratumumab + Lenalidomide + Dexamethasone (DRd)

Arm Description

Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.

Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (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 completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.

Outcomes

Primary Outcome Measures

Primary: Progression-free Survival (PFS)

PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.

Secondary Outcome Measures

Percentage of Participants With Complete Response (CR) or Better

CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.

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

VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. In participants with only measurable disease by serum FLC levels a >90% decrease in the difference between involved and uninvolved FLC levels is required.

Percentage of Participants With Negative Minimal Residual Disease (MRD)

MRD negativity rate is 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 date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.

Overall Response Rate (ORR)

ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as >=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. A >=50% reduction in the size of soft tissue plasmacytomas is also required.

Overall Survival (OS)

OS was measured from the date of randomization to the date of the death.

Time to Disease Progression (TTP)

TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.

Time to Response

Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. 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. A >=50% reduction in the size of soft tissue plasmacytomas is also required.

Duration of Response (DoR)

DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.

Time to Subsequent Anti-myeloma Treatment

Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.

Progression-free Survival on Next Line of Therapy (PFS2)

PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12

EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 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). 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 health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12

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.

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12

EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of 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 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 individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).

Full Information

NCT ID

NCT02252172

First Posted

August 11, 2014

Last Updated

October 10, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02252172

Brief Title

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Official Title

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) 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

February 16, 2015 (Actual)

Primary Completion Date

September 24, 2018 (Actual)

Study Completion Date

June 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

Detailed Description

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with newly diagnosed multiple myeloma and who are not candidates for high dose chemotherapy and ASCT. All the eligible participants will be randomly assigned to receive either lenalidomide and dexamethasone (Rd) (Arm A) or daratumumab in combination with lenalidomide and dexamethasone (DRd) (Arm B). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (from Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 40 mg once a week for both treatment arms. Participants in both treatment arms will continue lenalidomide and dexamethasone until disease progression or unacceptable toxicity. All participants randomized to Treatment Arm B (DRd) in this study initially received daratumumab IV formulation; however, following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (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 completion. Participants in Arm A who have sponsor-confirmed disease progression may have the option to receive daratumumab provided by the sponsor (in any subsequent line of therapy) in the Follow-up phase. The study consists of 3 phases: Screening Phase (within 21 days prior to the first dose administration on Day 1), Treatment Phase (Day 1 up to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, consent withdrawal, or study end, whichever occurs first). The maximum duration of study will be 7 years after last participant is randomized. Efficacy will primarily be evaluated by PFS. 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, Daratumumab, JNJ-54767414, Lenalidomide, Dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

737 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lenalidomide and Dexamethasone (Rd)

Arm Type

Active Comparator

Arm Description

Arm Title

Daratumumab + Lenalidomide + Dexamethasone (DRd)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Daratumumab IV

Other Intervention Name(s)

JNJ-54767414

Intervention Description

Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone 40 mg orally or intravenously once in a week.

Intervention Type

Drug

Intervention Name(s)

Daratumumab SC

Other Intervention Name(s)

JNJ-54767414

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 study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.

Primary Outcome Measure Information:

Title

Primary: Progression-free Survival (PFS)

Description

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Complete Response (CR) or Better

Description

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

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

Description

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Percentage of Participants With Negative Minimal Residual Disease (MRD)

Description

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Overall Response Rate (ORR)

Description

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Overall Survival (OS)

Description

OS was measured from the date of randomization to the date of the death.

Time Frame

From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Time to Disease Progression (TTP)

Description

TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.

Time Frame

From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Time to Response

Description

Time Frame

From randomization to first response (PR or better) (up to 7.8 years)

Title

Duration of Response (DoR)

Description

DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.

Time Frame

From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Time to Subsequent Anti-myeloma Treatment

Description

Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.

Time Frame

From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)

Title

Progression-free Survival on Next Line of Therapy (PFS2)

Description

Time Frame

From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)

Title

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12

Description

Time Frame

Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)

Title

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12

Description

Time Frame

Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)

Title

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12

Description

Time Frame

Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)

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 CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >=1.0 gram/deciliter [g/dL] or urine M-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >=0.5 g/dL or urine M-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab Man, who is sexually active with a woman of child-bearing potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab Exclusion Criteria: Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage) Participant has a diagnosis of Waldenström'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 a history of malignancy (other than multiple myeloma) within 5 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 5 years) 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 had radiation therapy within 14 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), persistent asthma, or a history of asthma within the last 2 years (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) or hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid [RNA] quantitation positive)

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

Birmingham

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Alabama

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Mobile

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Glendale

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Berkeley

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Beverly Hills

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El Cajon

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Greenbrae

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Los Angeles

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Oceanside

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San Diego

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West Hills

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Whittier

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Denver

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Fort Collins

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Glenwood Springs

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New Haven

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Norwalk

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Boca Raton

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Boynton Beach

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Fort Lauderdale

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Fort Myers

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Hollywood

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Jacksonville

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Lake City

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Saint Petersburg

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Weston

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Atlanta

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Augusta

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Macon

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Marietta

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Chicago

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Niles

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Marrero

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Shreveport

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Annapolis

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Baltimore

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Frederick

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Hooksett

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Brick

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Hackensack

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Livingston

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Plainfield

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Somerville

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Summit

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Mineola

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New York

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Rochester

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Asheboro

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City

Charlotte

State/Province

North Carolina

Country

United States

City

Pinehurst

State/Province

North Carolina

Country

United States

City

Winston-Salem

State/Province

North Carolina

Country

United States

City

Canton

State/Province

Ohio

Country

United States

City

Cleveland

State/Province

Ohio

Country

United States

City

Columbus

State/Province

Ohio

Country

United States

City

Bend

State/Province

Oregon

Country

United States

City

Bethlehem

State/Province

Pennsylvania

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

City

Spartanburg

State/Province

South Carolina

Country

United States

City

Sioux Falls

State/Province

South Dakota

Country

United States

City

Chattanooga

State/Province

Tennessee

Country

United States

City

Nashville

State/Province

Tennessee

Country

United States

City

Arlington

State/Province

Texas

Country

United States

City

Edinburg

State/Province

Texas

Country

United States

City

Fort Sam Houston

State/Province

Texas

Country

United States

City

Fort Worth

State/Province

Texas

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

Plano

State/Province

Texas

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

City

Ogden

State/Province

Utah

Country

United States

City

Seattle

State/Province

Washington

Country

United States

City

Spokane

State/Province

Washington

Country

United States

City

Tacoma

State/Province

Washington

Country

United States

City

Box Hill

Country

Australia

City

Fitzroy

Country

Australia

City

Footscray

Country

Australia

City

Kogarah

Country

Australia

City

Kurralta Park

Country

Australia

City

Nedlands

Country

Australia

City

New South Wales

Country

Australia

City

Woodville

Country

Australia

City

Woolloongabba N/a

Country

Australia

City

Innsbruck

Country

Austria

City

Linz

Country

Austria

City

Salzburg

Country

Austria

City

Wien N/a

Country

Austria

City

Wien Wien

Country

Austria

City

Brugge

Country

Belgium

City

Brussels

Country

Belgium

City

Brussel

Country

Belgium

City

Haine-saint-paul, LA Louviere

Country

Belgium

City

Leuven

Country

Belgium

City

Liege

Country

Belgium

City

Calgary

State/Province

Alberta

Country

Canada

City

Toronto

State/Province

Ontario

Country

Canada

City

Greenfield Park

State/Province

Quebec

Country

Canada

City

Montreal

State/Province

Quebec

Country

Canada

City

Montréal

State/Province

Quebec

Country

Canada

City

N/a N/a

Country

Canada

City

Nova Scotia

Country

Canada

City

Quebec

Country

Canada

City

Aarhus C

Country

Denmark

City

Odense

Country

Denmark

City

Vejle

Country

Denmark

City

Amiens N/a Picardie

Country

France

City

Angers

Country

France

City

Bayonne Cedex

Country

France

City

Bretagne

Country

France

City

Caen

Country

France

City

Cergy Pontoise

Country

France

City

Chalons Sur Saone

Country

France

City

Clermont-Ferrand

Country

France

City

Creteil

Country

France

City

Dijon

Country

France

City

Dunkerque Cedex 1

Country

France

City

Grenoble Cedex 9

Country

France

City

La Roche sur Yon Cedex 9

Country

France

City

Le Chesnay Cedex

Country

France

City

Le Mans

Country

France

City

Lille Cedex

Country

France

City

Lille

Country

France

City

Limoges

Country

France

City

Lyon, Pierre-Benite

Country

France

City

Marseille Cedex 9

Country

France

City

Metz-Tessy

Country

France

City

Montivilliers

Country

France

City

Montpellier

Country

France

City

Mulhouse

Country

France

City

Nantes

Country

France

City

Nice N/a

Country

France

City

Paris Cedex 12

Country

France

City

Paris, 75

Country

France

City

Paris

Country

France

City

PERIGUEUX cedex

Country

France

City

Perpignan

Country

France

City

Pessac

Country

France

City

Poitiers

Country

France

City

Reims

Country

France

City

Rennes

Country

France

City

Rouen Cedex

Country

France

City

Saint Brieuc Cedex 1

Country

France

City

Saint Priest en Jarez

Country

France

City

St Malo Cedex

Country

France

City

St Quentin Cedex

Country

France

City

Strasbourg

Country

France

City

Toulouse Cedex 9

Country

France

City

TOURS Cedex 9

Country

France

City

Vandoeuvre Les Nancy

Country

France

City

Aschaffenburg

Country

Germany

City

Bad Berka

Country

Germany

City

Bonn

Country

Germany

City

Braunschweig

Country

Germany

City

Dresden

Country

Germany

City

Essen

Country

Germany

City

Frankfurt

Country

Germany

City

Hannover

Country

Germany

City

Heidelberg

Country

Germany

City

Hessen

Country

Germany

City

Kiel

Country

Germany

City

Koblenz

Country

Germany

City

Mainz

Country

Germany

City

Mannheim

Country

Germany

City

Rostock

Country

Germany

City

Schwerin

Country

Germany

City

Stuttgart

Country

Germany

City

Tuebingen

Country

Germany

City

Ulm

Country

Germany

City

Villingen-Schwenningen

Country

Germany

City

Dublin

Country

Ireland

City

Galway

Country

Ireland

City

Hadera

Country

Israel

City

Haifa

Country

Israel

City

Jerusalem

Country

Israel

City

Nahariya

Country

Israel

City

Petah Tikva

Country

Israel

City

Tel-Aviv

Country

Israel

City

Hilversum

Country

Netherlands

City

Hoofddorp

Country

Netherlands

City

Rotterdam

Country

Netherlands

City

Tilburg

Country

Netherlands

City

Falun

Country

Sweden

City

Göteborg

Country

Sweden

City

Halmstad

Country

Sweden

City

Helsingborg

Country

Sweden

City

Huddinge

Country

Sweden

City

Lulea

Country

Sweden

City

Lund

Country

Sweden

City

Stockholm

Country

Sweden

City

Örebro

Country

Sweden

City

Aberdeen

Country

United Kingdom

City

Canterbury

Country

United Kingdom

City

Dundee

Country

United Kingdom

City

Leeds

Country

United Kingdom

City

London

Country

United Kingdom

City

Manchester

Country

United Kingdom

City

Nottingham

Country

United Kingdom

City

Oxford

Country

United Kingdom

City

Plymouth, Devon

Country

United Kingdom

City

Southampton

Country

United Kingdom

City

Truro

Country

United Kingdom

City

Wolverhampton

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36067063

Citation

Mateos MV, Rigaudeau S, Basu S, Spicka I, Schots R, Wrobel T, Cook G, Beksac M, Gries KS, Kudva A, Tromp B, Van Rampelbergh R, Pei H, Wroblewski S, Carson R, Delioukina M, White D. Switching to daratumumab SC from IV is safe and preferred by patients with multiple myeloma. J Oncol Pharm Pract. 2023 Jul;29(5):1172-1177. doi: 10.1177/10781552221103551. Epub 2022 Sep 6.

Results Reference

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PubMed Identifier

34655533

Citation

Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.

Results Reference

derived

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

derived

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

derived

PubMed Identifier

33326255

Citation

Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.

Results Reference

derived

PubMed Identifier

31141632

Citation

Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.

Results Reference

derived

Learn more about this trial

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

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