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History of Changes for Study: NCT02076009
A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Latest version (submitted April 23, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 27, 2014 None (earliest Version on record)
2 March 6, 2014 Outcome Measures, Study Status and Contacts/Locations
3 March 27, 2014 Contacts/Locations and Study Status
4 April 17, 2014 Study Status and Contacts/Locations
5 May 8, 2014 Study Status and Contacts/Locations
6 June 18, 2014 Recruitment Status, Contacts/Locations, Outcome Measures, Study Status, Study Design and Study Description
7 July 10, 2014 Contacts/Locations and Study Status
8 July 31, 2014 Contacts/Locations and Study Status
9 August 22, 2014 Contacts/Locations and Study Status
10 September 12, 2014 Contacts/Locations and Study Status
11 October 3, 2014 Contacts/Locations and Study Status
12 October 24, 2014 Contacts/Locations and Study Status
13 November 14, 2014 Contacts/Locations and Study Status
14 November 26, 2014 Contacts/Locations and Study Status
15 December 17, 2014 Contacts/Locations and Study Status
16 January 12, 2015 Study Status, Contacts/Locations and Eligibility
17 February 2, 2015 Contacts/Locations and Study Status
18 February 23, 2015 Contacts/Locations and Study Status
19 March 16, 2015 Contacts/Locations and Study Status
20 April 7, 2015 Contacts/Locations and Study Status
21 April 28, 2015 Contacts/Locations and Study Status
22 May 19, 2015 Contacts/Locations and Study Status
23 June 9, 2015 Contacts/Locations and Study Status
24 June 30, 2015 Contacts/Locations and Study Status
25 July 21, 2015 Contacts/Locations and Study Status
26 August 7, 2015 Recruitment Status, Contacts/Locations, Study Status and Study Design
27 November 23, 2015 Study Status and Study Design
28 February 26, 2016 Study Status
29 May 20, 2016 Study Status
30 June 23, 2016 Arms and Interventions, Study Status, Contacts/Locations and Study Description
31 September 21, 2016 Contacts/Locations, Study Status and Study Design
32 October 21, 2016 Study Status and Study Design
33 December 9, 2016 Outcome Measures, Study Status and Eligibility
34 December 20, 2016 Outcome Measures, Study Status and Results
35 February 16, 2017 Study Status, Baseline Characteristics, Study Design and Oversight
36 April 4, 2017 Study Status, Study Design and Oversight
37 June 1, 2017 Study Status and Oversight
38 July 27, 2017 Study Status
39 March 6, 2018 Study Status, Eligibility, Arms and Interventions and Study Description
40 January 31, 2019 Study Status
41 May 13, 2019 Study Status, Contacts/Locations and Study Design
42 June 13, 2019 Study Status and Study Design
43 August 22, 2019 Study Status
44 October 21, 2019 Study Status
45 January 7, 2020 Study Status
46 May 5, 2020 Arms and Interventions, Study Status and Study Description
47 June 25, 2020 Study Status
48 August 20, 2020 Study Status
49 October 15, 2020 Study Status and Contacts/Locations
50 January 8, 2021 Study Status
51 February 4, 2021 Study Status
52 March 4, 2021 Study Status
53 August 5, 2021 Baseline Characteristics, Study Status, Outcome Measures, Adverse Events, Arms and Interventions and Study Description
54 September 16, 2021 Study Status
55 October 14, 2021 Study Status
56 November 4, 2021 Contacts/Locations, Study Status and Study Design
57 December 2, 2021 Study Status and Contacts/Locations
58 December 30, 2021 Contacts/Locations and Study Status
59 January 27, 2022 Study Status
60 February 24, 2022 Study Status and Contacts/Locations
61 March 24, 2022 Study Status and Contacts/Locations
62 April 21, 2022 Study Status
63 May 19, 2022 Study Status
64 June 16, 2022 Study Status
65 July 14, 2022 Study Status
66 August 11, 2022 Study Status
67 September 8, 2022 Study Status
68 October 6, 2022 Study Status
69 November 3, 2022 Study Status
70 November 22, 2022 Study Status
71 December 20, 2022 Study Status
72 January 17, 2023 Study Status
73 February 14, 2023 Study Status
74 March 14, 2023 Study Status
75 April 4, 2023 Study Status and Contacts/Locations
76 April 12, 2023 Study Status
77 May 3, 2023 Study Status
78 May 30, 2023 Contacts/Locations and Study Status
79 June 28, 2023 Study Status
80 July 19, 2023 Study Status
81 August 15, 2023 Study Status and Study Design
82 September 12, 2023 Contacts/Locations and Study Status
83 October 10, 2023 Study Status
84 November 2, 2023 Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics and Study Status
85 December 5, 2023 Study Status
86 January 2, 2024 Study Status
87 January 30, 2024 Study Status
88 February 27, 2024 Study Status
89 March 26, 2024 Study Status
90 April 23, 2024 Study Status
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Study NCT02076009
Submitted Date:  February 27, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR103663
Brief Title: A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Official Title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary IDs: 54767414MMY3003 [Janssen Research & Development, LLC]
2013-005525-23 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Not yet recruiting
Study Start: April 2014
Primary Completion: May 2017 [Anticipated]
Study Completion: May 2017 [Anticipated]
First Submitted: February 27, 2014
First Submitted that
Met QC Criteria:
February 27, 2014
First Posted: March 3, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 27, 2014
Last Update Posted: March 3, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description: This is a randomized (participants will be assigned by chance to study treatments), open-label (all participants and study personnel will know the identity of the study treatments), active-controlled (none of the study treatments are placebo), parallel-group (both treatment arms will run at the same time), multicenter study. In this study, daratumumab, lenalidomide, and low-dose dexamethasone (DRd) will be compared with lenalidomide and low dose dexamethasone (Rd) in participants with relapsed or refractory multiple myeloma. Participants will be randomized in a 1:1 ratio to receive either DRd or Rd. The study will include a Screening Phase, a Treatment Phase (involving treatment cycles of approximately 28 days in length), and a Follow-up Phase. The Treatment Phase will extend from the administration of the first dose of study medication until disease progression or unacceptable toxicity. Participants will also discontinue study treatment if: they become pregnant; have their dose held for more than 28 days (or if 3 consecutive planned doses of daratumumab are missed for reasons other than toxicity); or for safety reasons (eg, adverse event). The Follow-up Phase will begin at the end of treatment and will continue until death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. The primary endpoint will be progression-free survival (PFS). Analysis of the primary endpoint is anticipated to be performed at approximately 12 months after the last subject is randomized. Study end is anticipated at approximately 5 years after the last subject is randomized. Blood and urine samples will be obtained at time points during the study, together with bone marrow aspirates/biopsies and skeletal surveys. Participant safety will be assessed throughout the study.
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Daratumumab
Lenalidomide
Dexamethasone
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Daratumumab + lenalidomide + dexamethasone
During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
Drug: 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; once only (on Day 1) during treatment cycles 7 onwards.
Drug: Lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
Drug: 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 < 8.5).
Active Comparator: Lenalidomide + dexamethasone
During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.
Drug: Lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
Drug: 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 < 8.5).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS)
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

PFS is defined as the duration from the time of randomization to either progressive disease or death, whichever occurs first.
Secondary Outcome Measures:
1. Time to disease progression (PD)
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

Time to disease progression is defined as the time from the date of randomization to the date of first documented evidence of PD.
2. Overall response rate
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

Overall response rate is defined as the percentage of participants who achieve complete response or partial response according to the International Myeloma Working Group criteria, during or after study treatment.
3. Number of participants who acheive very good partial response (VGPR) or better
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

"VGPR or better" is defined as the number of participants who acheive VGPR and complete response (CR) (including stringent CR) according to the International Myeloma Working Group criteria
4. Time to complete response (CR) or partial response (PR)
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

5. Overall survival
[ Time Frame: Up to approximately 5 years (anticipated) after the last participant is randomized ]

Overall survival is measured from the date of randomization to the date of the participant's death.
6. Duration of response
[ Time Frame: Up to approximately 12 months (anticipated) after the last participant is randomized ]

Duration of response will be calculated from the date of initial documentation of a response (complete response or partial response) to the date of first documented evidence of progressive disease.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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

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 3 years before the date of randomization
Open or close this module Contacts/Locations
Central Contact Person: This study is not yet recruiting patients. Please check back for future recruiting sites, or email
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Sweden
Falun, Sweden
Göteborg, Sweden
Helsingborg, Sweden
Huddinge, Sweden
Lund, Sweden
Stockholm, Sweden
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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