A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03277105 |
Recruitment Status :
Completed
First Posted : September 8, 2017
Results First Posted : July 27, 2020
Last Update Posted : March 13, 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: Dara SC Drug: Dara IV |
Enrollment | 522 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Daratumumab IV | Daratumumab SC |
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Arm/Group Description | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. |
Period Title: Overall Study | ||
Started | 259 | 263 |
Treated (Safety Analysis Set) | 258 | 260 |
Completed | 0 | 0 |
Not Completed | 259 | 263 |
Reason Not Completed | ||
Death | 129 | 124 |
Lost to Follow-up | 2 | 4 |
Withdrawal by Subject | 10 | 10 |
Other | 118 | 125 |
Baseline Characteristics
Arm/Group Title | Daratumumab IV | Daratumumab SC | Total | |
---|---|---|---|---|
Arm/Group Description | Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days. | Total of all reporting groups | |
Overall Number of Baseline Participants | 259 | 263 | 522 | |
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 | 259 participants | 263 participants | 522 participants | |
66.8 (10.16) | 65.3 (9.11) | 66.1 (9.66) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 259 participants | 263 participants | 522 participants | |
Female |
110 42.5%
|
127 48.3%
|
237 45.4%
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Male |
149 57.5%
|
136 51.7%
|
285 54.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 259 participants | 263 participants | 522 participants | |
Hispanic or Latino |
9 3.5%
|
14 5.3%
|
23 4.4%
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Not Hispanic or Latino |
227 87.6%
|
225 85.6%
|
452 86.6%
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Unknown or Not Reported |
23 8.9%
|
24 9.1%
|
47 9.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 259 participants | 263 participants | 522 participants | |
American Indian or Alaska Native |
0 0.0%
|
1 0.4%
|
1 0.2%
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Asian |
40 15.4%
|
32 12.2%
|
72 13.8%
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|
Native Hawaiian or Other Pacific Islander |
1 0.4%
|
0 0.0%
|
1 0.2%
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|
Black or African American |
5 1.9%
|
9 3.4%
|
14 2.7%
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|
White |
201 77.6%
|
207 78.7%
|
408 78.2%
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|
More than one race |
0 0.0%
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0 0.0%
|
0 0.0%
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|
Unknown or Not Reported |
12 4.6%
|
14 5.3%
|
26 5.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 259 participants | 263 participants | 522 participants |
AUSTRALIA |
15 5.8%
|
13 4.9%
|
28 5.4%
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|
BRAZIL |
10 3.9%
|
15 5.7%
|
25 4.8%
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|
CANADA |
16 6.2%
|
20 7.6%
|
36 6.9%
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|
CZECH REPUBLIC |
20 7.7%
|
16 6.1%
|
36 6.9%
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|
FRANCE |
6 2.3%
|
10 3.8%
|
16 3.1%
|
|
GREECE |
1 0.4%
|
6 2.3%
|
7 1.3%
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|
ISRAEL |
5 1.9%
|
8 3.0%
|
13 2.5%
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|
ITALY |
10 3.9%
|
16 6.1%
|
26 5.0%
|
|
JAPAN |
24 9.3%
|
18 6.8%
|
42 8.0%
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|
POLAND |
39 15.1%
|
26 9.9%
|
65 12.5%
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|
RUSSIAN FEDERATION |
28 10.8%
|
27 10.3%
|
55 10.5%
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|
SOUTH KOREA |
7 2.7%
|
4 1.5%
|
11 2.1%
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|
SPAIN |
14 5.4%
|
12 4.6%
|
26 5.0%
|
|
SWEDEN |
18 6.9%
|
18 6.8%
|
36 6.9%
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|
TAIWAN |
6 2.3%
|
8 3.0%
|
14 2.7%
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|
UKRAINE |
22 8.5%
|
25 9.5%
|
47 9.0%
|
|
UNITED KINGDOM |
16 6.2%
|
17 6.5%
|
33 6.3%
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UNITED STATES |
2 0.8%
|
4 1.5%
|
6 1.1%
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Stage of Disease (ISS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 259 participants | 263 participants | 522 participants |
Stage I |
94 36.3%
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82 31.2%
|
176 33.7%
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Stage II |
89 34.4%
|
101 38.4%
|
190 36.4%
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|
Stage III |
76 29.3%
|
79 30.0%
|
155 29.7%
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Data missing or Unknown |
0 0.0%
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1 0.4%
|
1 0.2%
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[1]
Measure Description: Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (>=) 3.5 grams (g) per 100 milliliter; Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/L.
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Number of prior lines
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 259 participants | 263 participants | 522 participants |
Less than or equal to (<=) 4 Lines |
175 67.6%
|
174 66.2%
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349 66.9%
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Greater than (>) 4 Lines |
84 32.4%
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89 33.8%
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173 33.1%
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Refractory status
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 259 participants | 263 participants | 522 participants |
Both protease inhibitor (PI) and immunomodulatory drug (IMiD) |
133 51.4%
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125 47.5%
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258 49.4%
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IMiD only |
81 31.3%
|
67 25.5%
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148 28.4%
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None |
26 10.0%
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41 15.6%
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67 12.8%
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PI only |
19 7.3%
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30 11.4%
|
49 9.4%
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Weight group
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 259 participants | 263 participants | 522 participants |
<=65 |
92 35.5%
|
94 35.7%
|
186 35.6%
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>65 - 85 |
105 40.5%
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102 38.8%
|
207 39.7%
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>85 |
61 23.6%
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66 25.1%
|
127 24.3%
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Not Reported |
1 0.4%
|
1 0.4%
|
2 0.4%
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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: | Global Medical Head |
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: | NCT03277105 |
Other Study ID Numbers: |
CR108342 2017-000206-38 ( EudraCT Number ) 54767414MMY3012 ( Other Identifier: Janssen Research & Development, LLC ) |
First Submitted: | September 7, 2017 |
First Posted: | September 8, 2017 |
Results First Submitted: | June 19, 2020 |
Results First Posted: | July 27, 2020 |
Last Update Posted: | March 13, 2024 |