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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02076009
Registration number
NCT02076009
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014
Date last updated
15/08/2024
Titles & IDs
Public title
A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
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Scientific title
Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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54767414MMY3003
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Secondary ID [2]
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CR103663
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Experimental: Daratumumab + lenalidomide + dexamethasone - During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
Active comparator: Lenalidomide + dexamethasone - During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.
Treatment: Drugs: Daratumumab
Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; and every 4 weeks for cycles 7 and onwards. Following amendment 8, participants receiving daratumumab IV have the option to switch to daratumumab subcutaneous (SC) 1800 mg/dose until documented progression, unacceptable toxicity, or the end of study on Day 1 of any cycle, at the discretion of the investigator.
Treatment: Drugs: Lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
Treatment: Drugs: Dexamethasone
Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants \> 75 years old or with a body mass index \< 18.5).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (\>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder.
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Timepoint [1]
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From randomization to either disease progression or death whichever occurs first (up to 21 months)
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Secondary outcome [1]
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Time to Disease Progression (TTP)
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Assessment method [1]
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TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new 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.
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Timepoint [1]
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From randomization to disease progression (up to 21 months)
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Secondary outcome [2]
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Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better
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Assessment method [2]
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VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: 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, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
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Timepoint [2]
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From randomization to disease progression (up to 21 months)
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Secondary outcome [3]
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Percentage of Participants With Negative Minimal Residual Disease (MRD)
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Assessment method [3]
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Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry. The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^ minus (-) 4, 10\^-5, 10\^-6 threshold.
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Timepoint [3]
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From randomization to the date of first documented evidence of PD (up to 87.5 months)
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Secondary outcome [4]
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Overall Response Rate
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Assessment method [4]
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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 or after study treatment. IMWG criteria for 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, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.
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Timepoint [4]
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From randomization to disease progression (up to 21 months)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Overall survival was measured from the date of randomization to the date of the participant's death.
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Timepoint [5]
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From randomization to date of death due to any cause (up to 87.5 months)
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Secondary outcome [6]
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Time to Response
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Assessment method [6]
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Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.
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Timepoint [6]
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From randomization up to first documented CR or PR (up to 21 months)
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Secondary outcome [7]
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Duration of Response (DOR)
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Assessment method [7]
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DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \>10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5mg/dL) that can be attributed solely to PC proliferative disorder.
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Timepoint [7]
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From randomization to the date of first documented evidence of PD (up to 21 months)
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Secondary outcome [8]
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Time to Subsequent Anticancer Treatment
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Assessment method [8]
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Time to subsequent anticancer treatment was defined as the time from randomization to the start of subsequent anticancer treatment or death due to progressive disease (PD), whichever occurs first.
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Timepoint [8]
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From randomization to date of start of subsequent anticancer treatment or death due to PD, whichever occured first (up to 87.5 months)
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Eligibility
Key inclusion criteria
* Must have documented multiple myeloma and measurable disease
* Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
* Must have documented evidence of progressive disease as defined by the International Myeloma Working Group criteria on or after their last regimen
* Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
* If a participant has received subsequent anticancer therapy (salvage therapy), the participant must have a "wash-out period" defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the planned start date of daratumumab monotherapy. The only exception is the emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has received any of the following therapies: daratumumab or other anti-CD38 therapies
* Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
* Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
* Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
* History of malignancy (other than multiple myeloma) within 5 years before the first dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
569
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Camperdown
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- Geelong
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- Heidelberg
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- Malvern
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- South Brisbane
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- Southport
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- Camperdown
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- Geelong
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- Heidelberg
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- Malvern
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Recruitment postcode(s) [5]
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- South Brisbane
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Recruitment postcode(s) [6]
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- Southport
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Recruitment outside Australia
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Arkansas
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Poznan
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Russian Federation
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Dzerzhinsk
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan
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Russian Federation
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Samara
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Russian Federation
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Russian Federation
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St. Petersburg
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Russian Federation
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Lund
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Stockholm
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Uppsala
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Taoyuan
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United Kingdom
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Birmingham
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Surrey
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Wolverhampton
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Funding & Sponsors
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Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Summary
Brief summary
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
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Trial website
https://clinicaltrials.gov/study/NCT02076009
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Trial related presentations / publications
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. Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, Gries KS. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021 Jul;194(1):132-139. doi: 10.1111/bjh.17435. Epub 2021 Apr 6. Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29. Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020. Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT02076009
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