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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763370
Expanded Access Status : Available
First Posted : December 4, 2018
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate

Detailed Description:
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). 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.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Belantamab

Interventions
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Intervention Details:
  • Drug: Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate
    Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks
Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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-38 antibody (alone or in combinations if available)
  3. Disease Progression on last therapy
  4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated
  5. 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:

  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 1 dose of BLENREP

  2. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations

    For new patients

  3. 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
  4. No other treatment options available
  5. 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

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763370


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03763370    
Other Study ID Numbers: 209233
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Keywords provided by GlaxoSmithKline:
213304
belantamab mafodotin
Expanded Access Program
Multiple Myeloma
Additional relevant MeSH terms:
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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
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs