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

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sundar Jagannath, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02541643
First received: September 2, 2015
Last updated: NA
Last verified: September 2015
History: No changes posted
  Purpose
To provide elotuzumab treatment for single-patient use.

Condition Intervention
Multiple Myeloma Drug: Elotuzumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient R-A With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sundar Jagannath, Icahn School of Medicine at Mount Sinai:

Intervention Details:
    Drug: Elotuzumab

    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)
    Other Name: BMS-901608
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02541643

Locations
United States, New York
Icahn School.of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Sundar Jagannath
Bristol-Myers Squibb
Investigators
Principal Investigator: Sundar Jagannath, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Sundar Jagannath, Director of the Multiple Myeloma Program, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02541643     History of Changes
Other Study ID Numbers: GCO 14-2022
Study First Received: September 2, 2015
Last Updated: September 2, 2015

Keywords provided by Sundar Jagannath, Icahn School of Medicine at Mount Sinai:
Relapsed/Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2017