Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
NCT ID: NCT02477891
Last Updated: 2019-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Daratumumab
Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.
Eligibility Criteria
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Inclusion Criteria
* Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria: Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal to \[\>=\] 2 cycles or 2 months of treatment) and an IMiD (\>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) OR Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
Exclusion Criteria
* Subject receives any other anti-myeloma therapy while receiving daratumumab
* Enrolled in another interventional clinical study with therapeutic intent
* Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
* Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
* Prior exposure to any anti-CD38 monoclonal antibody
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Duarte, California, United States
Fountain Valley, California, United States
Gilroy, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
West Hollywood, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Great Falls, Montana, United States
Omaha, Nebraska, United States
Flemington, New Jersey, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Corvallis, Oregon, United States
Hershey, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Barretos, , Brazil
João Pessoa, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
Kobe, , Japan
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Volgograd, , Russia
Barcelona, , Spain
Granada, , Spain
Las Palmas de Gran Canaria, , Spain
Madrid, , Spain
Mallorca, , Spain
Pamplona, , Spain
Salamanca, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Toledo, , Spain
Valencia, , Spain
Valladolid, , Spain
Zaragoza, , Spain
Blackpool, , United Kingdom
Bournemouth, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
Kent, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Manchester, , United Kingdom
Newcastle, , United Kingdom
Nottingham, , United Kingdom
Stoke-on-Trent, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Cook G, Corso A, Streetly M, Mendeleeva LP, Ptushkin VV, Chan E, Ukropec J, Iraqi W, Al-Akabawi A, Pei H, Gaudig M, Petrucci MT, Alegre A, Mateos MV. Daratumumab Monotherapy for Relapsed or Refractory Multiple Myeloma: Results of an Early Access Treatment Protocol in Europe and Russia. Oncol Ther. 2021 Jun;9(1):139-151. doi: 10.1007/s40487-020-00137-x. Epub 2021 Feb 25.
Crusoe EQ, Pimenta FCF, Maiolino A, Castro NS, Pei H, Trufelli D, Fernandez M, Herriot LB. Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma. Hematol Transfus Cell Ther. 2021 Oct-Dec;43(4):417-423. doi: 10.1016/j.htct.2020.07.005. Epub 2020 Sep 14.
Other Identifiers
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54767414MMY3010
Identifier Type: OTHER
Identifier Source: secondary_id
2015-002993-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR106626
Identifier Type: -
Identifier Source: org_study_id
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