A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (study 208887 DREAMM 5)
- Conditions
- multiple myeloma10018865
- Registration Number
- NL-OMON54690
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• Males and females, age 18 years and above.
• Histologically or cytologically confirmed multiple myeloma (MM).
• Treated with at least 3 prior lines of prior anti-myeloma treatments
including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38
monoclonal antibody. See protocol section 5.1, item 3.
• Eligibility in case of prior autologous stem cell transplant: transplant >
100 days before and no active infections.
• ECOG performance status 0-1
• Measurable disease. For further details: see protocol section 5.1, item 6.
• Adequate organ function. For further details: see protocol section 5.1, item
7.
• Participants positive for Hepatitis B core antibody can het enrolled if the
following criteria are met:
- Serology results: HBcAb+, HBsAg-
- Screening: HBV DNA undetectable
- During Study Treatment: Monitoring per protocol, initiating
antiviral treatment if HBV DNA becomes detectable.
• Participants who are currently receiving physiological doses oral steroids,
inhaled steroid or ophthalmalogical steroids are allowed on the study.
• Males must agree to follow a required contraceptive method during the study
and during 6 months after the last dose of study medication (condom, even if
they have undergone vasectomy). For further details: see protocol section 5.1,
item 9.
• Not pregnant or breastfeeding females and females of non-reproductive
potential or reproductive potential and agrees to follow a required
contraceptive method during the study and during 4 months after the last dose
of study medication. For further details: see protocol section 5.1, item 9.
• Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia.
• Corneal epithelial disease. For further details: see protocol section 5.2,
item 3.
• Current unstable liver or biliary disease per investigator assessment. For
further details: see protocol section 5.2, item 4.
• Malignancy other than disease under study. For further details: see protocol
section 5.2, item 5.
• Evidence of cardiovascular risk. For further details: see protocol section
5.2, item 6.
• Active infection requiring systemic therapy, known HIV infection, positive
test for hepatitis B or hepatitis C. For further details: see protocol section
5.2, item 8-12.
• Within the past 6 months: acute diverticulitis, inflammatory bowel disease,
intra-abdominal abscess, or gastrointestinal obstruction
• Presence of active renal conditions (infection, requirement of dialysis or
any other condition that could affect participant's safety). Participants with
isolated proteinuria resulting from MM are eligible, provided they fulfill
criteria given in table 15 of the protocol.
• Prior or concomitant therapies listed in protocol section 5.2, item 13-20.
• Within 6 months: uncontrolled symptomatic ascites or pleural or pericardial
effusions.
• Life vaccine within 30 days of first dose of study medication. For further
details: see protocol section 5.2, item 23.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>DOSE EXPLORATION:<br /><br>Dose limiting toxicities, adverse events.<br /><br><br /><br>EXPANSION:<br /><br>Overall response rate (ORR).</p><br>
- Secondary Outcome Measures
Name Time Method <p>DOSE EXPLORATION:<br /><br>ORR. GSK2857916 and other anti-cancer treatment concentrations in plasma.<br /><br>Anti-drug antibodies.<br /><br><br /><br>EXPANSION:<br /><br>Clinical benefit rate (CBR), progression free survival (PFS). Adverse events.<br /><br>GSK2857916 and other anti-cancer treatment concentrations in plasma. Anti-drug<br /><br>antibodies.</p><br>