Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

A
Attaya Suvannasankha, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase N/A
1 participants needed
4 Locations

Brief description of study

What is the purpose of this study?
Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma. Patients considering this access program should have no other therapeutic option, and not eligible for other clinical trials. US patients who have been treated through the REMS program are eligible to enroll in this program.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • Belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. 
  • This program is intended to provide access to belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 Years
  • Gender: All

Individual Patient IND:
INCLUSION CRITERIA:
  1. Written informed consent
  2. Diagnosis of RRMM and/or plasma cell dyscrasias and:
    1. Has failed 4 prior therapies
    2. Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38body (alone or in combinations if available)
  3. Disease Progression on last therapy
  4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatmentycles and as clinically indicated
  5. Contraception requirements
    1. Female Participants: A female patient is eligible to participate if one of the followingditions applies:
    2. The patient Is not a woman of childbearing potential (WOCBP)OR II. The patient Is aWOCBP and using an effective contraceptive method during treatment with belantamabdotin and for 4 months after the last dose. The patient must also have a negativehighly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discusswith GSK physician if the patient is pregnant, breast-feeding or planning to have a baby.
    3. Male participants with female partners of child-bearing potential are eligible tohey agree to use effective contraception during treatment with belantamabdotin until 6 months after the last dose
EXCLUSION CRITERIA:
  1. Evidence of Active Bleeding
  2. Currently Active GVHD
  3. Known Hypersensitivity to the active substance or to any of the excipients
  4. Previous progression on belantamab mafodotin
US Expanded Access (group) Protocol:
INCLUSION CRITERIA:
For patients currently receiving BLENREP through the REMS program
  1. Patients currently enrolled in the BLENREP REMS program who have received at least 1dose of BLENREP
  2. Written informed consent can be obtained from the patient or legally authorizedve as per local regulations
    For new patients
  3. New patients diagnosed with RRMM who have received at least 4 prior therapies,uding an anti-CD38 monoclonal antibody, a proteasome inhibitor, and anunomodulatory agent
  4. No other treatment options available
  5. Written informed consent can be obtained from the patient or legally authorizedve as per local regulations
EXCLUSION CRITERIA:
For patients currently receiving BLENREP through the REMS program
  1. Previously progressed on treatment with belantamab mafodotin.
  2. Patient is pregnant or breastfeeding
For new patients
  1. Previously progressed on treatment with belantamab mafodotin.
  2. Patient is pregnant or breastfeeding

Updated on 01 Aug 2024. Study ID: 209233, ECRO-GSK-BELANTAMAB-EAP, 17807
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