Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03277105




Registration number
NCT03277105
Ethics application status
Date submitted
7/09/2017
Date registered
8/09/2017
Date last updated
13/03/2024

Titles & IDs
Public title
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2017-000206-38
Secondary ID [2] 0 0
CR108342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dara SC
Treatment: Drugs - Dara IV

Experimental: Dara SC - Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.

Active comparator: Dara IV - Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.


Treatment: Drugs: Dara SC
Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.

Treatment: Drugs: Dara IV
Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 1 year 8 months
Primary outcome [2] 0 0
Maximum Trough Concentration (Ctrough) of Daratumumab
Timepoint [2] 0 0
Predose on Cycle 3 Day 1 (each cycle of 28 days)
Secondary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Percentage of Participants With Very Good Partial Response (VGPR) or Better
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Percentage of Participants With Complete Response (Including sCR) or Better
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Time to Next Therapy
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
Timepoint [7] 0 0
Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
Secondary outcome [8] 0 0
Duration of Response
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Time to Partial Response (PR) or Better
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Time to Very Good Partial Response (VGPR) or Better
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
Time to Complete Response (CR) or Better
Timepoint [11] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen
* Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy
* Documented multiple myeloma as defined by the criteria below:

1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
2. Measurable disease at Screening as defined by any of the following:

1. Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Meet the clinical laboratory criteria as specified in the protocol
* Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received daratumumab or other anti-CD38 therapies previously
* Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
* Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
* Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
* History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2024
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Brazil
State/province [3] 0 0
Barretos
Country [4] 0 0
Brazil
State/province [4] 0 0
Florianopolis
Country [5] 0 0
Brazil
State/province [5] 0 0
Jau
Country [6] 0 0
Brazil
State/province [6] 0 0
Joinville
Country [7] 0 0
Brazil
State/province [7] 0 0
Passo Fundo
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio de Janeiro
Country [10] 0 0
Brazil
State/province [10] 0 0
Salvador
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Jose do Rio Preto
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czechia
State/province [20] 0 0
Olomouc
Country [21] 0 0
Czechia
State/province [21] 0 0
Ostrava
Country [22] 0 0
Czechia
State/province [22] 0 0
Plzen
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 10
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 2
Country [25] 0 0
France
State/province [25] 0 0
Caen
Country [26] 0 0
France
State/province [26] 0 0
Lille Cedex
Country [27] 0 0
France
State/province [27] 0 0
Nantes Cedex 1
Country [28] 0 0
France
State/province [28] 0 0
Pessac
Country [29] 0 0
France
State/province [29] 0 0
Pierre-Bénite
Country [30] 0 0
France
State/province [30] 0 0
Poitiers
Country [31] 0 0
France
State/province [31] 0 0
Vandoeuvre Les Nancy
Country [32] 0 0
Greece
State/province [32] 0 0
Athens Attica
Country [33] 0 0
Israel
State/province [33] 0 0
Hadera
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Petah Tikva
Country [37] 0 0
Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Aviv
Country [39] 0 0
Italy
State/province [39] 0 0
Bologna
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Palermo
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia
Country [43] 0 0
Italy
State/province [43] 0 0
Piacenza
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Torino
Country [46] 0 0
Japan
State/province [46] 0 0
Fukuoka
Country [47] 0 0
Japan
State/province [47] 0 0
Fukuyama
Country [48] 0 0
Japan
State/province [48] 0 0
Gifu
Country [49] 0 0
Japan
State/province [49] 0 0
Gunma
Country [50] 0 0
Japan
State/province [50] 0 0
Hyogo
Country [51] 0 0
Japan
State/province [51] 0 0
Iwate
Country [52] 0 0
Japan
State/province [52] 0 0
Kyoto
Country [53] 0 0
Japan
State/province [53] 0 0
Matsuyama
Country [54] 0 0
Japan
State/province [54] 0 0
Nagoya
Country [55] 0 0
Japan
State/province [55] 0 0
Niigata
Country [56] 0 0
Japan
State/province [56] 0 0
Okayama
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
State/province [58] 0 0
Sendai-City
Country [59] 0 0
Japan
State/province [59] 0 0
Shibukawa
Country [60] 0 0
Japan
State/province [60] 0 0
Shibuya
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Busan
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Goyang-Si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Incheon
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Ulsan
Country [66] 0 0
Poland
State/province [66] 0 0
Brzozow
Country [67] 0 0
Poland
State/province [67] 0 0
Bydgoszcz
Country [68] 0 0
Poland
State/province [68] 0 0
Chorzów
Country [69] 0 0
Poland
State/province [69] 0 0
Gdynia
Country [70] 0 0
Poland
State/province [70] 0 0
Krakow
Country [71] 0 0
Poland
State/province [71] 0 0
Legnica
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Poznan
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Dzerzhinsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Ekaterinburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Nizny Novgorod
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Penza
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Ryazan
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Saint-Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Samara
Country [83] 0 0
Russian Federation
State/province [83] 0 0
St-Petersburg
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Syktyvkar
Country [85] 0 0
Spain
State/province [85] 0 0
Badalona
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Girona
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Spain
State/province [89] 0 0
La Laguna
Country [90] 0 0
Spain
State/province [90] 0 0
Leon
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Pamplona
Country [93] 0 0
Spain
State/province [93] 0 0
Pozuelo de Alarcon
Country [94] 0 0
Spain
State/province [94] 0 0
Salamanca
Country [95] 0 0
Spain
State/province [95] 0 0
Valencia
Country [96] 0 0
Sweden
State/province [96] 0 0
Falun
Country [97] 0 0
Sweden
State/province [97] 0 0
Helsingborg
Country [98] 0 0
Sweden
State/province [98] 0 0
Huddinge
Country [99] 0 0
Sweden
State/province [99] 0 0
Lund
Country [100] 0 0
Sweden
State/province [100] 0 0
Umea
Country [101] 0 0
Sweden
State/province [101] 0 0
Uppsala
Country [102] 0 0
Taiwan
State/province [102] 0 0
Changhua
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taichung City
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taichung,
Country [105] 0 0
Taiwan
State/province [105] 0 0
Tainan
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taipei
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taoyuan
Country [108] 0 0
Ukraine
State/province [108] 0 0
Cherkasy
Country [109] 0 0
Ukraine
State/province [109] 0 0
Dnepropetrovsk
Country [110] 0 0
Ukraine
State/province [110] 0 0
Ivano-Frankivsk
Country [111] 0 0
Ukraine
State/province [111] 0 0
Kharkiv
Country [112] 0 0
Ukraine
State/province [112] 0 0
Kiev
Country [113] 0 0
Ukraine
State/province [113] 0 0
Lviv
Country [114] 0 0
Ukraine
State/province [114] 0 0
Mykolaiv
Country [115] 0 0
Ukraine
State/province [115] 0 0
Poltava
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Blackpool
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bournemouth
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Leicester
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Manchester
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Nottingham
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Surrey
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03277105