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Compassionate Use Individual Request Program for GSK2857916 in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03763370
Expanded Access Status : Available
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Compassionate use access to GSK2857916 for eligible participants with refractory/relapsing multiple myeloma

Condition or disease Intervention/treatment
Multiple Myeloma Drug: GSK2857916 anti-BCMA-ADC

Detailed Description:
GSK2857916 is a humanized IgG1 monoclonal ADC that binds specifically to B-Cell Maturation Antigen. Compassionate use is restricted to Relapsed/Refractory Multiple Myeloma (MM) patients who have failed at least three lines of prior therapy including an anti-CD38 antibody, if available, and refractory to a proteasome inhibitor and an immunomodulatory agent. Patients should also be ineligible for all currently approved standard of care for 4L+ MM in the requesting country.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Compassionate Use Individual Request Program for GSK2857916 in Multiple Myeloma



Intervention Details:
  • Drug: GSK2857916 anti-BCMA-ADC
    Dose and schedule: BCMA-ADC 3.4mg/kg IV Q3wks

Information from the National Library of Medicine

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

Inclusion Criteria:

Adequate organ system functions.

Criteria for Determining Adequate Organ System Function:

Lab Parameter -- Laboratory Values Absolute Neutrophil count -- (ANC) / ≥ 1.0 X 109/L Hemoglobin -- ≥ 7.0 g/dL Platelets -- ≥ 50 X 109/L Total bilirubin -- ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) ALT -- ≤2.5 X ULN or <5 times ULN if documented liver infiltration eGFR (as calculated MDRD equation) -- ≥ 30 mL/min/ 1.73 m2 (monotherapy)

Contraception:

  1. Female Participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    • Is not a woman of childbearing potential (WOCBP) OR
    • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 80 days after the last dose of GSK2857916 and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The physician should evaluate the effectiveness of the contraceptive method in relationship to the first dose of GSK2857916.

    A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of GSK2857916.

    The physician is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

  2. Male Participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 140 days after last dose of GSK2857916:

• Refrain from donating sperm

PLUS either:

• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

OR

• Must agree to use contraception/barrier as detailed below: Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

Exclusion Criteria:

  1. Evidence of active bleeding requiring intervention within the last four weeks.
  2. Current corneal epithelial disease except mild punctate keratopathy.
  3. Any major surgery within the last four weeks.
  4. Prior allogeneic stem cell transplant (SCT). Exception: syngeneic transplant
  5. Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria given in Inclusion #1.
  6. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety or compliance to the procedures.
  7. Current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
  8. Malignancies other than disease under study are excluded, except for any other malignancy from which the participant is not being actively treated with cytotoxic chemotherapy and/or radiation within 5 ½ half-lives, whichever is shorter. Hormonal Therapy for disease is acceptable.
  9. Evidence of cardiovascular risk including any of the following:

    1. QTcF interval ≥480 msecs (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
    2. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
    3. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of first dose.
    4. Class III or IV heart failure as defined by the New York Heart Association functional classification system
    5. Uncontrolled hypertension
  10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916.
  11. Active infection requiring antibiotic, antiviral, or antifungal treatment.
  12. Known HIV infection.
  13. Presence of hepatitis B surface antigen (HBsAg), at or within 3 months prior to request for GSK2857916 under compassionate use.
  14. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at or within 3 months prior to request for GSK2857916 under compassionate use.

Note: Positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.

Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.


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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03763370     History of Changes
Other Study ID Numbers: 209233
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
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