Compassionate Use Individual Request Program for GSK2857916 in Multiple Myeloma

Overview

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.

SparkCures ID 985
Trial Phase Expanded Access
Enrollment Information Not Available
Treatments
Tags
Trial Sponsors
  • GlaxoSmithKline
NCT Identifier

NCT03763370

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

Resources

GSK Compassionate Use (Expanded Access) Request Portal

GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.