- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763370
Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma
Expanded Access Program for Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma Who Are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Expanded Access Type
- Individual Patients
- Treatment IND/Protocol
Contacts and Locations
Study Contact
- Name: US GSK Clinical Trials Call Center
- Phone Number: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Individual Patient IND:
INCLUSION CRITERIA:
- Written informed consent
Diagnosis of RRMM and/or plasma cell dyscrasias and:
- Has failed 4 prior therapies
- Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38 antibody (alone or in combinations if available)
- Disease Progression on last therapy
- Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated
- Contraception requirements
A. Female Participants: A female patient is eligible to participate if one of the following conditions applies:
I. The patient Is not a woman of childbearing potential (WOCBP)OR II. The patient Is a WOCBP and using an effective contraceptive method during treatment with belantamab mafodotin and for 4 months after the last dose. The patient must also have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discuss with GSK physician if the patient is pregnant, breast-feeding or planning to have a baby.
B. Male participants with female partners of child-bearing potential are eligible to participate if they agree to use effective contraception during treatment with belantamab mafodotin until 6 months after the last dose
EXCLUSION CRITERIA:
- Evidence of Active Bleeding
- Currently Active GVHD
- Known Hypersensitivity to the active substance or to any of the excipients
- Previous progression on belantamab mafodotin
US Expanded Access (group) Protocol:
INCLUSION CRITERIA:
For patients currently receiving BLENREP through the REMS program
- Patients currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP
Written informed consent can be obtained from the patient or legally authorized representative as per local regulations
For new patients
- New patients diagnosed with RRMM who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
- No other treatment options available
- Written informed consent can be obtained from the patient or legally authorized representative as per local regulations
EXCLUSION CRITERIA:
For patients currently receiving BLENREP through the REMS program
- Previously progressed on treatment with belantamab mafodotin.
- Patient is pregnant or breastfeeding
For new patients
- Previously progressed on treatment with belantamab mafodotin.
- Patient is pregnant or breastfeeding
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Immunologic Factors
- Immunoconjugates
Other Study ID Numbers
- 209233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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