Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
An Open-Label Treatment Use Protocol for Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or Are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent
3 other identifiers
expanded_access
N/A
6 countries
79
Brief Summary
The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedJanuary 15, 2019
January 1, 2019
June 15, 2015
January 11, 2019
Conditions
Keywords
Interventions
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
You may qualify if:
- Subject must be at least 18 years of age
- 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
You may not qualify if:
- Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Gilroy, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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West Hollywood, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Ocala, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Omaha, Nebraska, United States
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Flemington, New Jersey, United States
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Corvallis, Oregon, United States
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Hershey, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Fairfax, Virginia, United States
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Barretos, Brazil
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João Pessoa, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Kobe, Japan
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Moscow, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Volgograd, Russia
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Barcelona, Spain
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Granada, Spain
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Las Palmas de Gran Canaria, Spain
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Madrid, Spain
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Mallorca, Spain
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Pamplona, Spain
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Salamanca, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Toledo, Spain
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Valencia, Spain
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Valladolid, Spain
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Zaragoza, Spain
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Blackpool, United Kingdom
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Bournemouth, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Kent, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Londonderry, United Kingdom
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Manchester, United Kingdom
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Newcastle, United Kingdom
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Nottingham, United Kingdom
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Stoke-on-Trent, United Kingdom
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Wolverhampton, United Kingdom
Related Publications (2)
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.
PMID: 33630275DERIVEDCrusoe 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.
PMID: 32967807DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC