Clinical trial NCT02477891: Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Daratumumab
Early access
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Detailed description: This is a multicenter, open-label, early access treatment protocol of single-agent daratumumab in subjects with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD, who reside in areas where daratumumab is not commercially available or available through another protocol, who have not been enrolled in another daratumumab study, and who are not eligible for or who do not have access to enrollment in another ongoing clinical study of daratumumab. The study will have three phases: Screening phase (30 days prior to first dose of study drug), treatment phase (until documented progression, unacceptable toxicity, or study end), End of Treatment (30 days after last dose of study drug). Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion. Participants will primarily be assessed for overall response rate. Safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Duarte
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Gilroy
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: West Hollywood
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Flemington
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Corvallis
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Barretos
country: Brazil
city: Joao Pessoa
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Kobe-City
country: Japan
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Las Palmas De Gran Canaria
country: Spain
city: Madrid
country: Spain
city: Mallorca
country: Spain
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Santiago De Compostela
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
city: Blackpool
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Kent
country: United Kingdom
city: Leeds
country: United Kingdom
city: Londonderry
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Stoke On Trent
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.