Multiple MyelomaNCT02477891
Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
A study testing Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 79 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 79 sitesin 6 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
79 sites in 6 countries.
79 sites in 6 countries
United States41 sites
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Bethesda, Maryland
Study site
Boise, Idaho
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Corvallis, Oregon
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Fairfax, Virginia
Study site
Flemington, New Jersey
Study site
Fountain Valley, California
Study site
Gilroy, California
Study site
Great Falls, Montana
Study site
Greenbrae, California
Study site
Greenville, South Carolina
Study site
Hackensack, New Jersey
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Jacksonville, Florida
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
New Brunswick, New Jersey
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Ocala, Florida
Study site
Omaha, Nebraska
Study site
Phoenix, Arizona
Study site
St Louis, Missouri
Study site
Topeka, Kansas
Study site
West Hollywood, California
Study site
West Palm Beach, Florida
Spain13 sites
Study site
Barcelona
Study site
Granada
Study site
Las Palmas de Gran Canaria
Study site
Madrid
Study site
Mallorca
Study site
Pamplona
Study site
Salamanca
Study site
Santander
Study site
Santiago de Compostela
Study site
Toledo
Study site
Valencia
Study site
Valladolid
Study site
Zaragoza
United Kingdom13 sites
Study site
Blackpool
Study site
Bournemouth
Study site
Dundee
Study site
Glasgow
Study site
Kent
Study site
Leeds
Study site
London
Study site
Londonderry
Study site
Manchester
Study site
Newcastle
Study site
Nottingham
Study site
Stoke-on-Trent
Study site
Wolverhampton
Brazil6 sites
Study site
Barretos
Study site
João Pessoa
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo
Russia5 sites
Study site
Moscow
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Samara
Study site
Volgograd
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab
- Keywords
- Multiple myeloma, Daratumumab, Early access
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477891
- Sponsor's protocol ID
- CR106626
- Other IDs
- 54767414MMY3010, 2015-002993-19, 2015
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
Publications
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.
PubMed 33630275Crusoe 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.
PubMed 32967807
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02477891
- Acronym / sponsor ID
- CR106626
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Daratumumab, Early access
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaratumumabParticipants 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 33630275Cook 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.
- Derived from this study: PubMed 32967807Crusoe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
79 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 79 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Spain, United Kingdom, Brazil, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02477891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.