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

Sundar Jagannath

Status

Conditions: Multiple Myeloma

Treatments: Drug: Elotuzumab

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT02541643

GCO 14-2022

Details and patient eligibility

About

To provide elotuzumab treatment for single-patient use.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.