Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT01080391 |
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Recruitment Status :
Completed
First Posted : March 4, 2010
Results First Posted : July 8, 2015
Last Update Posted : September 21, 2022
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Relapsed Multiple Myeloma |
| Interventions |
Drug: Dexamethasone Drug: Lenalidomide Drug: Carfilzomib |
| Enrollment | 792 |
Participant Flow
| Recruitment Details | Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017). |
| Pre-assignment Details | Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes). |
| Arm/Group Title | Lenalidomide and Dexamethasone (Rd) | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) |
|---|---|---|
 Arm/Group Description |
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. | Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle. |
| Period Title: Overall Study | ||
| Started | 396 | 396 |
| Treated | 389 | 392 |
| Completed [1] | 389 | 392 |
| Not Completed | 7 | 4 |
| Reason Not Completed | ||
| Randomized but not treated | 7 | 4 |
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[1]
Completed represents patients who discontinued treatment as of 05 December 2017
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Baseline Characteristics
| Arm/Group Title | Lenalidomide and Dexamethasone (Rd) | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. | Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 396 | 396 | 792 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| 64.5 (9.04) | 63.3 (9.21) | 63.9 (9.14) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| Female |
164 41.4%
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181 45.7%
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345 43.6%
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| Male |
232 58.6%
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215 54.3%
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447 56.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| American Indian or Alaska Native |
1 0.3%
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0 0.0%
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1 0.1%
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| Asian/Native Hawaiian or Pacific Islander |
3 0.8%
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1 0.3%
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4 0.5%
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| Black or African American |
11 2.8%
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12 3.0%
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23 2.9%
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| White |
377 95.2%
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377 95.2%
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754 95.2%
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| Other |
4 1.0%
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6 1.5%
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10 1.3%
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Serum β2 Microglobulin
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| < 2.5 mg/L |
77 19.4%
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77 19.4%
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154 19.4%
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| ≥ 2.5 mg/L |
319 80.6%
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319 80.6%
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638 80.6%
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Prior Bortezomib Exposure
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| Yes |
261 65.9%
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261 65.9%
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522 65.9%
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| No |
135 34.1%
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135 34.1%
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270 34.1%
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Prior Lenalidomide Exposure
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 396 participants | 396 participants | 792 participants | |
| Yes |
78 19.7%
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80 20.2%
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158 19.9%
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| No |
318 80.3%
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316 79.8%
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634 80.1%
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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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Amgen Inc. |
| Phone: | 866-572-6436 |
| EMail: | medinfo@amgen.com |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01080391 |
| Other Study ID Numbers: |
PX-171-009 |
| First Submitted: | March 2, 2010 |
| First Posted: | March 4, 2010 |
| Results First Submitted: | June 8, 2015 |
| Results First Posted: | July 8, 2015 |
| Last Update Posted: | September 21, 2022 |