Multiple Myeloma Clinical Trial
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
Summary
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Full Description
The study population will consist of adults diagnosed with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be assessed at scheduled time. Follow-up will continue until the end of the data collection period, approximately 24 months after the last participant was randomized or when the median overall survival for both arms has been reached, whichever occurs first. The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.
Eligibility Criteria
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:
Multiple myeloma diagnosis according to the IMWG diagnostic criteria
Measurable disease at Screening as defined by any of the following:
Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or
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
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
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There are 145 Locations for this study
Boston Massachusetts, 02215, United States
Charlotte North Carolina, 28204, United States
Camperdown , 2050, Australia
Fitzroy , 3065, Australia
Melbourne , 3004, Australia
Murdoch , 6150, Australia
Nedlands , 6009, Australia
Waratah , 2298, Australia
Woodville South , 5011, Australia
Woolloongabba , 4102, Australia
Barretos , 14784, Brazil
Florianopolis , 88034, Brazil
Jau , 17210, Brazil
Joinville , 89201, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 90035, Brazil
Rio de Janeiro , 22775, Brazil
Salvador , 45995, Brazil
Sao Jose do Rio Preto , 15090, Brazil
São Paulo , 01455, Brazil
São Paulo , 05403, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 1, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 1, Canada
Québec Quebec, G1R 2, Canada
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Ostrava , 70852, Czechia
Plzen , 323 0, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Caen , 14033, France
Lille Cedex , 59000, France
Nantes Cedex 1 , 44093, France
Pessac , 33604, France
Pierre-Bénite , 69495, France
Poitiers , 86021, France
Vandoeuvre Les Nancy , 54511, France
Athens Attica , 115 2, Greece
Hadera , 38100, Israel
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bologna , 40138, Italy
Milano , 20133, Italy
Palermo , 90146, Italy
Pavia , 27100, Italy
Piacenza , 29121, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Torino , 10126, Italy
Fukuoka , 814-0, Japan
Fukuyama , 720-0, Japan
Gifu , 503-8, Japan
Gunma , 371-0, Japan
Hyogo , 650-0, Japan
Iwate , 020-8, Japan
Kyoto , 602-8, Japan
Matsuyama , 790-8, Japan
Nagoya , 466-8, Japan
Nagoya , 467-8, Japan
Niigata , 951-8, Japan
Okayama , 701-1, Japan
Osaka , 565-0, Japan
Sendai-City , 983-8, Japan
Shibukawa , 377-0, Japan
Shibuya , 150-8, Japan
Busan , 49241, Korea, Republic of
Goyang-Si , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Brzozow , 36-20, Poland
Bydgoszcz , 85-16, Poland
Chorzów , 41-50, Poland
Gdynia , 81-51, Poland
Krakow , 31-50, Poland
Legnica , 59-22, Poland
Lublin , 20-08, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Dzerzhinsk , 60601, Russian Federation
Ekaterinburg , 62013, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 12930, Russian Federation
Nizny Novgorod , 60312, Russian Federation
Penza , 44007, Russian Federation
Ryazan , 39003, Russian Federation
Saint-Petersburg , 12318, Russian Federation
Samara , 44309, Russian Federation
St-Petersburg , 19102, Russian Federation
Syktyvkar , 16790, Russian Federation
Badalona , 08916, Spain
Barcelona , 08036, Spain
Girona , 17007, Spain
Granada , 18014, Spain
La Laguna , 38320, Spain
Leon , 24080, Spain
Madrid , 28007, Spain
Madrid , 28031, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Salamanca , 37007, Spain
Valencia , 46017, Spain
Falun , 79182, Sweden
Helsingborg , 25187, Sweden
Huddinge , 141 8, Sweden
Lund , 222 4, Sweden
Umea , 907 4, Sweden
Uppsala , SE-75, Sweden
Changhua , 50006, Taiwan
Taichung City , 40447, Taiwan
Taichung, , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 10048, Taiwan
Taoyuan , 33305, Taiwan
Cherkasy , 18009, Ukraine
Dnepropetrovsk , 49102, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Kharkiv , 61024, Ukraine
Kiev , 03022, Ukraine
Kiev , 03115, Ukraine
Kiev , 03115, Ukraine
Lviv , 79044, Ukraine
Mykolaiv , 54000, Ukraine
Poltava , 36011, Ukraine
Blackpool , FY3 8, United Kingdom
Bournemouth , BH7 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
London , SE1 9, United Kingdom
Manchester , M20 9, United Kingdom
Nottingham , NG5 1, United Kingdom
Surrey , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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