Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT02477891

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Daratumumab

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.

Study Design

Study Type:

Expanded Access

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Little Rock	Arkansas	United States
3	Duarte	California	United States
4	Fountain Valley	California	United States
5	Gilroy	California	United States
6	Greenbrae	California	United States
7	Los Angeles	California	United States
8	West Hollywood	California	United States
9	Denver	Colorado	United States
10	New Haven	Connecticut	United States
11	Jacksonville	Florida	United States
12	Ocala	Florida	United States
13	West Palm Beach	Florida	United States
14	Atlanta	Georgia	United States
15	Boise	Idaho	United States
16	Chicago	Illinois	United States
17	Indianapolis	Indiana	United States
18	Iowa City	Iowa	United States
19	Topeka	Kansas	United States
20	Louisville	Kentucky	United States
21	Baltimore	Maryland	United States
22	Bethesda	Maryland	United States
23	Boston	Massachusetts	United States
24	Detroit	Michigan	United States
25	Saint Louis	Missouri	United States
26	Great Falls	Montana	United States
27	Omaha	Nebraska	United States
28	Flemington	New Jersey	United States
29	Hackensack	New Jersey	United States
30	New Brunswick	New Jersey	United States
31	Buffalo	New York	United States
32	New York	New York	United States
33	Chapel Hill	North Carolina	United States
34	Charlotte	North Carolina	United States
35	Corvallis	Oregon	United States
36	Hershey	Pennsylvania	United States
37	Charleston	South Carolina	United States
38	Greenville	South Carolina	United States
39	Dallas	Texas	United States
40	Houston	Texas	United States
41	Fairfax	Virginia	United States
42	Barretos		Brazil
43	Joao Pessoa		Brazil
44	Porto Alegre		Brazil
45	Rio De Janeiro		Brazil
46	Salvador		Brazil
47	Sao Paulo		Brazil
48	Kobe-City		Japan
49	Moscow		Russian Federation
50	Novosibirsk		Russian Federation
51	Saint-Petersburg		Russian Federation
52	Samara		Russian Federation
53	Volgograd		Russian Federation
54	Barcelona		Spain
55	Granada		Spain
56	Las Palmas De Gran Canaria		Spain
57	Madrid		Spain
58	Mallorca		Spain
59	Pamplona		Spain
60	Salamanca		Spain
61	Santander		Spain
62	Santiago De Compostela		Spain
63	Toledo		Spain
64	Valencia		Spain
65	Valladolid		Spain
66	Zaragoza		Spain
67	Blackpool		United Kingdom
68	Bournemouth		United Kingdom
69	Dundee		United Kingdom
70	Glasgow		United Kingdom
71	Kent		United Kingdom
72	Leeds		United Kingdom
73	Londonderry		United Kingdom
74	London		United Kingdom
75	Manchester		United Kingdom
76	Newcastle		United Kingdom
77	Nottingham		United Kingdom
78	Stoke On Trent		United Kingdom
79	Wolverhampton		United Kingdom