Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT02252172 |
Recruitment Status :
Active, not recruiting
First Posted : September 30, 2014
Results First Posted : January 9, 2020
Last Update Posted : April 25, 2024
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Multiple Myeloma |
Interventions |
Drug: Daratumumab IV Drug: Lenalidomide Drug: Dexamethasone Drug: Daratumumab SC |
Enrollment | 737 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Lenalidomide + Dexamethasone (Rd) | Daratumumab + Lenalidomide + Dexamethasone (DRd) |
---|---|---|
Arm/Group Description | Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity. | Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity. |
Period Title: Overall Study | ||
Started | 369 | 368 |
Treated | 365 | 364 |
Completed [1] | 90 | 69 |
Not Completed | 279 | 299 |
Reason Not Completed | ||
Lost to Follow-up | 3 | 1 |
Ongoing | 276 | 298 |
[1]
Participants who died or withdrew consent were considered as completed.
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Baseline Characteristics
Arm/Group Title | Lenalidomide + Dexamethasone (Rd) | Daratumumab + Lenalidomide + Dexamethasone (DRd) | Total | |
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Arm/Group Description | Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity. | Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity. | Total of all reporting groups | |
Overall Number of Baseline Participants | 369 | 368 | 737 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 369 participants | 368 participants | 737 participants | |
74.2 (5.66) | 74.0 (5.44) | 74.1 (5.55) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 369 participants | 368 participants | 737 participants | |
Female |
174 47.2%
|
179 48.6%
|
353 47.9%
|
|
Male |
195 52.8%
|
189 51.4%
|
384 52.1%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 369 participants | 368 participants | 737 participants | |
Hispanic or Latino |
12 3.3%
|
11 3.0%
|
23 3.1%
|
|
Not Hispanic or Latino |
352 95.4%
|
347 94.3%
|
699 94.8%
|
|
Unknown or Not Reported |
5 1.4%
|
10 2.7%
|
15 2.0%
|
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 369 participants | 368 participants | 737 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
2 0.5%
|
3 0.8%
|
5 0.7%
|
|
Native Hawaiian or Other Pacific Islander |
1 0.3%
|
0 0.0%
|
1 0.1%
|
|
Black or African American |
16 4.3%
|
12 3.3%
|
28 3.8%
|
|
White |
339 91.9%
|
336 91.3%
|
675 91.6%
|
|
Other |
6 1.6%
|
6 1.6%
|
12 1.6%
|
|
Unknown or Not Reported |
5 1.4%
|
11 3.0%
|
16 2.2%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 369 participants | 368 participants | 737 participants |
AUSTRALIA |
18 4.9%
|
17 4.6%
|
35 4.7%
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|
AUSTRIA |
11 3.0%
|
3 0.8%
|
14 1.9%
|
|
BELGIUM |
5 1.4%
|
2 0.5%
|
7 0.9%
|
|
CANADA |
28 7.6%
|
24 6.5%
|
52 7.1%
|
|
DENMARK |
6 1.6%
|
10 2.7%
|
16 2.2%
|
|
FRANCE |
155 42.0%
|
157 42.7%
|
312 42.3%
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|
GERMANY |
16 4.3%
|
19 5.2%
|
35 4.7%
|
|
IRELAND |
3 0.8%
|
4 1.1%
|
7 0.9%
|
|
ISRAEL |
3 0.8%
|
5 1.4%
|
8 1.1%
|
|
ITALY |
3 0.8%
|
3 0.8%
|
6 0.8%
|
|
NETHERLANDS |
1 0.3%
|
4 1.1%
|
5 0.7%
|
|
SWEDEN |
12 3.3%
|
10 2.7%
|
22 3.0%
|
|
UNITED KINGDOM |
34 9.2%
|
33 9.0%
|
67 9.1%
|
|
UNITED STATES |
74 20.1%
|
77 20.9%
|
151 20.5%
|
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Stage of Disease (ISS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 369 participants | 368 participants | 737 participants |
Stage I |
103 27.9%
|
98 26.6%
|
201 27.3%
|
|
Stage II |
156 42.3%
|
163 44.3%
|
319 43.3%
|
|
Stage III |
110 29.8%
|
107 29.1%
|
217 29.4%
|
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[1]
Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/L.
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Time from Multiple Myeloma (MM) diagnosis
[1] Mean (Standard Deviation) Unit of measure: Months |
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Number Analyzed | 369 participants | 368 participants | 737 participants | |
1.3 (1.4) | 1.4 (1.5) | 1.3 (1.5) | ||
[1]
Measure Description: Time from MM diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Name/Title: | Director |
Organization: | Janssen Research & Development, LLC |
Phone: | 844-434-4210 |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT02252172 |
Other Study ID Numbers: |
CR104762 54767414MMY3008 ( Other Identifier: Janssen Research & Development, LLC ) 2014-002273-11 ( EudraCT Number ) |
First Submitted: | August 11, 2014 |
First Posted: | September 30, 2014 |
Results First Submitted: | September 24, 2019 |
Results First Posted: | January 9, 2020 |
Last Update Posted: | April 25, 2024 |