Trial Review

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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
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Plzen
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Czechia
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Praha 10
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Czechia
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Praha 2
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France
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Caen
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France
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Lille Cedex
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France
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Nantes Cedex 1
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France
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Pessac
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France
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Pierre-Bénite
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France
State/province [30] 0 0
Poitiers
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France
State/province [31] 0 0
Vandoeuvre Les Nancy
Country [32] 0 0
Greece
State/province [32] 0 0
Athens Attica
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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
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Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Aviv
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Italy
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Bologna
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Italy
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Milano
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Piacenza
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Italy
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Roma
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Italy
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Torino
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Japan
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Fukuoka
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Japan
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Fukuyama
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Japan
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Gifu
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Japan
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Gunma
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Japan
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Hyogo
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Japan
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Iwate
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Kyoto
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Matsuyama
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Nagoya
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Niigata
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Okayama
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Osaka
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Sendai-City
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Shibukawa
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Shibuya
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Busan
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Goyang-Si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Poland
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Brzozow
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Bydgoszcz
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Chorzów
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Gdynia
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Krakow
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Legnica
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Lublin
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Poznan
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Poland
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Warszawa
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Russian Federation
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Dzerzhinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Nizny Novgorod
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Russian Federation
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Penza
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Russian Federation
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St-Petersburg
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Russian Federation
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Syktyvkar
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Badalona
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Barcelona
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Girona
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Granada
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La Laguna
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Spain
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Leon
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Madrid
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Spain
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Pamplona
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Spain
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Pozuelo de Alarcon
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Spain
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Salamanca
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Spain
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Valencia
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Sweden
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Falun
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Sweden
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Helsingborg
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Sweden
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Huddinge
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Sweden
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Lund
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Sweden
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Umea
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Sweden
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Uppsala
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Taiwan
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Changhua
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Taiwan
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Taichung City
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Taiwan
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Taichung,
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [108] 0 0
Ukraine
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Cherkasy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Mykolaiv
Country [115] 0 0
Ukraine
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Poltava
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United Kingdom
State/province [116] 0 0
Blackpool
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United Kingdom
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Bournemouth
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
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Surrey
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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