Multiple MyelomaNCT02541643
Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma
A study testing Elotuzumab in people with Multiple Myeloma, run by Sundar Jagannath at 1 site in United States.
Trial summary
To provide elotuzumab treatment for single-patient use. 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?
- Elotuzumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- 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
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent
- Before any program procedures are performed, the patient will have the details of the program described to him or her, and she or he will be given a written informed consent document to read. Then, if the patient consents to participate in the program, she or he will indicate that consent by signing and dating the informed consent document in the presence of program personnel.
- Other Criteria
- Patients must be willing to refrain from blood donations during program drug therapy and for 8 weeks after therapy.
- Age and Reproductive Status
- Men and women, aged 18 years
Show all 11Show fewer
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- Women must not be breastfeeding
- WOCBP must use method(s) of contraception as indicated in the Informed Consent Form. Because of the teratogenic potential of elotuzumab, a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. In this study men and WOCBP must be using methods of contraception for at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90 days, after the last dose of elotuzumab.
- Males who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCB must agree to follow instructions for method(s) of contraception for the duration of treatment with elotuzumab plus 5 half-lives of the program drug plus 90 days (duration of sperm turnover) for a total of 90 days post-treatment completion.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile and azoospermic men do not require contraception.
Who cannot join
- Sex and Reproductive Status
- WOCBP not using 2 forms of effective birth control.
- Women with a positive pregnancy test at enrollment or prior to administration of program medication.
- Other Exclusion Criteria
- Prisoners or patients who are involuntarily incarcerated.
- Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Elotuzumab CA204022 BMS-901608 Expanded Access Guidance Document 23 Eligibility criteria for this program have been carefully considered to ensure the safety of the program patients and to ensure that the results of the program can be used. It is imperative that patients fully meet all eligibility criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School.of Medicine at Mount Sinai
New York, New York, 10029
About this study
To provide elotuzumab treatment for single-patient use.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called BMS-901608
Elotuzumab will be administered intravenously at a dose of 10mg/kg weekly (Days 1, 8, 15, and 22 of a 4-233k cycle) of the first 2 cycles and every 2 weeks (Day 1 and Day 15) thereafter.
A window of -1 to +3 days is permitted in Cycles 1 and 2. In Cycle 1 and 2, an elotuzumab dose that falls outside of the pre-specified window must be skipped. In Cycles 3 and beyond, elotuzumab dosing may be delayed for up to 1 week as clinically indicated. If unable to administer within 1 week, then the dose should be skipped and resumption of the elotuzumab continues per the guidance document defined schedule. In addition the following premedication must also be administered 30-90 minutes prior to any elotuzumab:
- H1 blocker: diphenhydramine (25-50mg PO or IV) or equivalent
- H2 blocker: ranitidine (50mg IV) or equivalent
- acetaminophen (650-1000mg PO)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Sundar Jagannath
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Sundar Jagannath, Icahn School of Medicine at Mount Sinai
- Investigators
- Sundar Jagannath, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541643
- Sponsor's protocol ID
- GCO 14-2022
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02541643
- Acronym / sponsor ID
- GCO 14-2022
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed/Refractory Multiple Myeloma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Sundar JagannathUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- First posted
- 4 Sep 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.
To provide elotuzumab treatment for single-patient use.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed Written Informed Consent
- Other Criteria
- Age and Reproductive Status
Key exclusion criteria (7 listed)
- Sex and Reproductive Status
- Other Exclusion Criteria
- Elotuzumab CA204022 BMS-901608 Expanded Access Guidance Document 23 Eligibility criteria for this program have been carefully considered to ensure the safety of the program patients and to ensure that the results of the program can be used. It is imperative that patients fully meet all eligibility criteria.
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 |
|---|---|---|
| ElotuzumabAlso: BMS-901608Elotuzumab will be administered intravenously at a dose of 10mg/kg weekly (Days 1, 8, 15, and 22 of a 4-233k cycle) of the first 2 cycles and every 2 weeks (Day 1 and Day 15) thereafter. A window of -1 to +3 days is permitted in Cycles 1 and 2. In Cycle 1 and 2, an elotuzumab dose that falls outside of the pre-specified window must be skipped. In Cycles 3 and beyond, elotuzumab dosing may be delayed for up to 1 week as clinically indicated. If unable to administer within 1 week, then the dose should be skipped and resumption of the elotuzumab continues per the guidance document defined schedule. In addition the following premedication must also be administered 30-90 minutes prior to any elotuzumab: * H1 blocker: diphenhydramine (25-50mg PO or IV) or equivalent * H2 blocker: ranitidine (50mg IV) or equivalent * acetaminophen (650-1000mg PO) | 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 4 Sep 2015.
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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.
Sundar Jagannath, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elotuzumab in people with Multiple Myeloma, run by Sundar Jagannath at 1 site in United States.
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 11 inclusion and 7 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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 4 Sep 2015.