A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT02195479 |
Recruitment Status :
Active, not recruiting
First Posted : July 21, 2014
Results First Posted : December 17, 2018
Last Update Posted : April 29, 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: Velcade Drug: Melphalan Drug: Prednisone Drug: Daratumumab IV Drug: Dexamethasone Drug: Daratumumab SC |
Enrollment | 706 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Results are reported up to second interim analysis (up to 2.4 years). Complete data through 6.4 years will be reported within 1 year of end of study trial date when final data based on study completion date will be available. |
Arm/Group Title | Velcade, Melphalan and Prednisone (VMP) | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) |
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Arm/Group Description | Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. | Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute. |
Period Title: Overall Study | ||
Started | 356 | 350 |
Treated | 354 | 346 |
Completed | 0 [1] | 0 [1] |
Not Completed | 356 | 350 |
Reason Not Completed | ||
Lost to Follow-up | 3 | 0 |
Death | 48 | 45 |
Physician Decision | 1 | 0 |
Withdrawal by Subject | 11 | 6 |
Other | 2 | 2 |
Ongoing | 291 | 297 |
[1]
None of the participants completed the study as the study is still on-going.
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Baseline Characteristics
Arm/Group Title | Velcade, Melphalan and Prednisone (VMP) | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Total | |
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Arm/Group Description | Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. | Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute. | Total of all reporting groups | |
Overall Number of Baseline Participants | 356 | 350 | 706 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 356 participants | 350 participants | 706 participants | |
71.5 (5.82) | 71.3 (6.66) | 71.4 (6.25) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 356 participants | 350 participants | 706 participants | |
Female |
189 53.1%
|
190 54.3%
|
379 53.7%
|
|
Male |
167 46.9%
|
160 45.7%
|
327 46.3%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 356 participants | 350 participants | 706 participants | |
Hispanic or Latino |
16 4.5%
|
24 6.9%
|
40 5.7%
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|
Not Hispanic or Latino |
332 93.3%
|
320 91.4%
|
652 92.4%
|
|
Unknown or Not Reported |
8 2.2%
|
6 1.7%
|
14 2.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 356 participants | 350 participants | 706 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
45 12.6%
|
47 13.4%
|
92 13.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
3 0.8%
|
3 0.9%
|
6 0.8%
|
|
White |
304 85.4%
|
297 84.9%
|
601 85.1%
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|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
4 1.1%
|
3 0.9%
|
7 1.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
||||
Argentina | Number Analyzed | 356 participants | 350 participants | 706 participants |
2 0.6%
|
2 0.6%
|
4 0.6%
|
||
Australia | Number Analyzed | 356 participants | 350 participants | 706 participants |
10 2.8%
|
5 1.4%
|
15 2.1%
|
||
Belgium | Number Analyzed | 356 participants | 350 participants | 706 participants |
8 2.2%
|
6 1.7%
|
14 2.0%
|
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Brazil | Number Analyzed | 356 participants | 350 participants | 706 participants |
2 0.6%
|
4 1.1%
|
6 0.8%
|
||
Bulgaria | Number Analyzed | 356 participants | 350 participants | 706 participants |
15 4.2%
|
8 2.3%
|
23 3.3%
|
||
Croatia | Number Analyzed | 356 participants | 350 participants | 706 participants |
2 0.6%
|
2 0.6%
|
4 0.6%
|
||
Czech Republic | Number Analyzed | 356 participants | 350 participants | 706 participants |
29 8.1%
|
21 6.0%
|
50 7.1%
|
||
Georgia | Number Analyzed | 356 participants | 350 participants | 706 participants |
11 3.1%
|
11 3.1%
|
22 3.1%
|
||
Germany | Number Analyzed | 356 participants | 350 participants | 706 participants |
2 0.6%
|
5 1.4%
|
7 1.0%
|
||
Greece | Number Analyzed | 356 participants | 350 participants | 706 participants |
15 4.2%
|
14 4.0%
|
29 4.1%
|
||
Hungary | Number Analyzed | 356 participants | 350 participants | 706 participants |
12 3.4%
|
14 4.0%
|
26 3.7%
|
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Italy | Number Analyzed | 356 participants | 350 participants | 706 participants |
26 7.3%
|
28 8.0%
|
54 7.6%
|
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Japan | Number Analyzed | 356 participants | 350 participants | 706 participants |
26 7.3%
|
24 6.9%
|
50 7.1%
|
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Poland | Number Analyzed | 356 participants | 350 participants | 706 participants |
27 7.6%
|
39 11.1%
|
66 9.3%
|
||
Portugal | Number Analyzed | 356 participants | 350 participants | 706 participants |
4 1.1%
|
3 0.9%
|
7 1.0%
|
||
Macedonia | Number Analyzed | 356 participants | 350 participants | 706 participants |
10 2.8%
|
1 0.3%
|
11 1.6%
|
||
Romania | Number Analyzed | 356 participants | 350 participants | 706 participants |
18 5.1%
|
10 2.9%
|
28 4.0%
|
||
Russia | Number Analyzed | 356 participants | 350 participants | 706 participants |
21 5.9%
|
22 6.3%
|
43 6.1%
|
||
Serbia | Number Analyzed | 356 participants | 350 participants | 706 participants |
3 0.8%
|
7 2.0%
|
10 1.4%
|
||
Korea, Democratic People'S Republic Of | Number Analyzed | 356 participants | 350 participants | 706 participants |
18 5.1%
|
23 6.6%
|
41 5.8%
|
||
Spain | Number Analyzed | 356 participants | 350 participants | 706 participants |
47 13.2%
|
56 16.0%
|
103 14.6%
|
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Turkey | Number Analyzed | 356 participants | 350 participants | 706 participants |
10 2.8%
|
5 1.4%
|
15 2.1%
|
||
Ukraine | Number Analyzed | 356 participants | 350 participants | 706 participants |
20 5.6%
|
28 8.0%
|
48 6.8%
|
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United Kingdom | Number Analyzed | 356 participants | 350 participants | 706 participants |
15 4.2%
|
9 2.6%
|
24 3.4%
|
||
United States | Number Analyzed | 356 participants | 350 participants | 706 participants |
3 0.8%
|
3 0.9%
|
6 0.8%
|
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Stage of Disease (ISS)
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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I | Number Analyzed | 331 participants | 333 participants | 664 participants |
38 11.5%
|
47 14.1%
|
85 12.8%
|
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II | Number Analyzed | 331 participants | 333 participants | 664 participants |
247 74.6%
|
226 67.9%
|
473 71.2%
|
||
III | Number Analyzed | 331 participants | 333 participants | 664 participants |
46 13.9%
|
60 18.0%
|
106 16.0%
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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.
[2]
Measure Analysis Population Description: Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this study specific characteristic.
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Time from multiple myeloma (MM) diagnosis
[1] Mean (Standard Deviation) Unit of measure: Months |
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Number Analyzed | 356 participants | 350 participants | 706 participants | |
1.27 (1.737) | 1.09 (1.056) | 1.18 (1.442) | ||
[1]
Measure Description: Time from multiple myeloma (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.
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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: | Executive Medical Director |
Organization: | Janssen Research and 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: | NCT02195479 |
Other Study ID Numbers: |
CR104761 54767414MMY3007 ( Other Identifier: Janssen Research and Development, LLC ) 2014-002272-88 ( EudraCT Number ) |
First Submitted: | July 18, 2014 |
First Posted: | July 21, 2014 |
Results First Submitted: | November 21, 2018 |
Results First Posted: | December 17, 2018 |
Last Update Posted: | April 29, 2024 |