Asymptomatic Myeloma
Conditions
Brief summary
The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in Multiple Myeloma (MM) and other indications.
Interventions
DRUGAtezolizumab (1200mg via IV infusion)
Patients will get atezolizumab every 21 days for up to 1 year
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet the following criteria for study entry: * All patients must sign an Informed Consent Form (ICF) approved by Institutional Review Board, and express ability and willingness to comply with the requirements of the study protocol. * Patients must meet criteria for high risk AMM defined as: * Bone marrow plasma cells ≥ 10% and/or levels of monoclonal protein (M-protein) \>3 g/dL and * Abnormal FLC ratio and absence of end organ damage (CRAB) defined as: lytic bone lesions on skeletal survey, calcium ≥ 11mg/dl, hemoglobin value of \>2 g/100 ml below the lower limit of normal or a hemoglobin value \<10 g/100 ml and renal insufficiency(serum creatinine \>0.173 mmol/l) Note: Patients with BMPC \> 60%, serum free light chain ratio \>100, or known to have 2 or greater focal lesions on MRI and are clinically felt to require therapy will not be included. * Measurable disease defined by: M-spike \>1 g/dL, or Bence Jones protein \> 200 mg/24 hours by urine protein electrophoresis or involved serum free light chain (FLC) \>10 mg /dl * Adequate hematologic and end organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment (Cycle 1, Day 1): * ANC ≥ 1500 cells/ µL * WBC counts \> 2500/ µL * Lymphocyte count ≥ 300/ µL * Platelet count ≥ 75,000/ µL * Total bilirubin within normal range * AST and ALT within normal range * Serum creatinine within normal range or creatinine clearance ≥ 60 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) x (weight in kg) x (0.85 if female) / 72 x (serum creatinine in mg/dL) * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 90 days after the last dose of study drug. * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: * With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 90 days after the last dose of study drug. Men must refrain from donating sperm during this same period. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion criteria
Patients who meet any of the following criteria will be excluded from study entry. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of anti-SOX2 reactive T cells after Anti-PDL1 therapy | Up to 1 year | Presence or absence of SOX2 cells before and after anti-PDL1 therapy followed up to 1 year will be measured using antigen dependant stimulation. |
Countries
United States
Outcome results
None listed