Clinical trial NCT02541643: Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma
Official title: Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Keywords: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2015-09-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: To provide elotuzumab treatment for single-patient use.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School.of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sundar Jagannath, MD
role: PRINCIPAL_INVESTIGATOR
References: