Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma



Status:No longer available
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016

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To provide elotuzumab treatment for single-patient use.


Inclusion Criteria:

- Signed Written Informed Consent

a) 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

a) Patients must be willing to refrain from blood donations during program drug
therapy and for 8 weeks after therapy.

- Age and Reproductive Status

1. Men and women, aged 18 years

2. 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.

3. Women must not be breastfeeding

4. 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.

5. 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.

6. Women who are not of childbearing potential (ie, who are postmenopausal or
surgically sterile and azoospermic men do not require contraception.

Exclusion Criteria:

- Sex and Reproductive Status

1. WOCBP not using 2 forms of effective birth control.

2. Women with a positive pregnancy test at enrollment or prior to administration of
program medication.

- Other Exclusion Criteria

1. Prisoners or patients who are involuntarily incarcerated.

2. 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.
We found this trial at
1
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New York, New York 10029
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