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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

NCT02541643 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2015-09-04

No results posted yet for this study

Summary

To provide elotuzumab treatment for single-patient use.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Sundar Jagannath, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541643 on ClinicalTrials.gov