A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT02076009 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2014
Results First Posted : February 10, 2017
Last Update Posted : January 11, 2021
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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 Drug: Lenalidomide Drug: Dexamethasone |
Enrollment | 569 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Lenalidomide, Low-dose Dexamethasone (Rd) | Daratumumab, Lenalidomide, Dexamethasone (DRd) |
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Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5). | Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was 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). |
Period Title: Overall Study | ||
Started | 283 | 286 |
Treated | 281 | 283 |
Completed | 0 | 0 |
Not Completed | 283 | 286 |
Reason Not Completed | ||
Death | 44 | 30 |
Withdrawal by Subject | 9 | 3 |
Lost to Follow-up | 1 | 1 |
Progressive disease | 1 | 0 |
Ongoing | 226 | 249 |
Subjects randomized but not treated | 2 | 3 |
Baseline Characteristics
Arm/Group Title | Lenalidomide, Low-dose Dexamethasone (Rd) | Daratumumab, Lenalidomide, Dexamethasone (DRd) | Total | |
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Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5). | Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was 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). | Total of all reporting groups | |
Overall Number of Baseline Participants | 283 | 286 | 569 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 283 participants | 286 participants | 569 participants | |
64.3 (8.84) | 64.4 (9.03) | 64.4 (8.93) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 283 participants | 286 participants | 569 participants | |
Female |
119 42.0%
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113 39.5%
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232 40.8%
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Male |
164 58.0%
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173 60.5%
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337 59.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 283 participants | 286 participants | 569 participants |
Australia | 9 | 9 | 18 | |
Belgium | 10 | 12 | 22 | |
Canada | 17 | 17 | 34 | |
Denmark | 7 | 10 | 17 | |
France | 36 | 21 | 57 | |
Germany | 7 | 11 | 18 | |
Greece | 8 | 11 | 19 | |
Israel | 20 | 19 | 39 | |
Japan | 15 | 21 | 36 | |
Korea, Republic of | 20 | 20 | 40 | |
Netherlands | 3 | 1 | 4 | |
Poland | 13 | 15 | 28 | |
Russian Federation | 30 | 18 | 48 | |
Spain | 25 | 26 | 51 | |
Sweden | 15 | 16 | 31 | |
Taiwan, Province of China | 9 | 11 | 20 | |
United Kingdom | 24 | 27 | 51 | |
United States | 15 | 21 | 36 | |
Stage of Disease (ISS)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 283 participants | 286 participants | 569 participants |
I | 140 | 137 | 277 | |
II | 86 | 93 | 179 | |
III | 57 | 56 | 113 | |
[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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No. of Prior Lines of Therapy
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 283 participants | 286 participants | 569 participants |
1 | 146 | 149 | 295 | |
2 | 80 | 85 | 165 | |
3 | 38 | 38 | 76 | |
>3 | 19 | 14 | 33 |
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, Clinical Research |
Organization: | Janssen R&D US |
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: | NCT02076009 |
Other Study ID Numbers: |
CR103663 54767414MMY3003 ( Other Identifier: Janssen Research & Development, LLC ) 2013-005525-23 ( EudraCT Number ) |
First Submitted: | February 27, 2014 |
First Posted: | March 3, 2014 |
Results First Submitted: | December 20, 2016 |
Results First Posted: | February 10, 2017 |
Last Update Posted: | January 11, 2021 |