Depleted Immune Suppressor Stem Cell Transplant in Enhancing Immune Response to Vaccines in Patients with Multiple Myeloma

Inclusion Criteria

• Diagnosis of multiple myeloma as per updated International Myeloma Working Group (IMWG) criteria
• Must have measurable disease defined as: for secretory MM, serum monoclonal protein >= 1.0 g/dL, urine monoclonal protein >= 200 mg/24 hrs, and involved free light chain >= 10 mg/dL; or in case of non-secretory MM, bone marrow plasma cell percentage >= 30%
• Must have standard risk myeloma
• Must have received bortezomib, lenalidomide and dexamethasone (VRd) as a form of induction therapy pre-autologous hematopoietic stem cell transplantation (AHSCT) (use of cyclophosphamide, bortezomib and dexamethasone may be allowed for up to 2 weekly doses before initiation of VRd induction, if necessary clinically for cytoreduction)
• Able to understand and sign a consent form
• Creatinine clearance equal or > 60 ml/min (calculated)
• Ejection fraction equal or > 50% before admission for transplant as per institutional standards; patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months or arrhythmia) need to be cleared by cardiology as per Emory bone marrow transplant (BMT) standards
• Total bilirubin =< 2.5 times the upper limit of the institutional normal values
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the upper limit of the institutional normal values
• Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted- before admission for transplant as per institutional standards; patients on home oxygen are not allowed on the protocol
• No more than 6 months of pre-transplant MM chemotherapy is allowed (from the date of the start of the induction therapy)
• Karnofsky performance status (KPS) >= 70% or Eastern Cooperative Oncology Group (ECOG) 0-2
• A female of child-bearing potential, must have two negative urine pregnancy test results within 10 to 14 days prior to starting the first dose of vaccine and Revlimid pre-transplant as a way of ensuring safe transplant planning

Exclusion Criteria

• Participation in another clinical study with an investigational product during the last 28 days
• Prior stem cell transplant (either autologous or allogeneic)
• Creatinine clearance < 60 ml/min (calculated)
• High risk MM defined as those with the following disease, fluorescence in situ hybridization and/or cytogenetic features: del17p, del1p with 1q gain, t(4;14), t(14;16), t(14;20), > 1 cytogenetic abnormality on karyotype, hypodiploid, plasma cell leukemia (primary or secondary), or subjects who failed to achieve >= partial response (PR) to induction therapy (i.e. VRd) and required salvage induction prior to AHSCT
• Documented central nervous system or extramedullary disease
• Significant organ dysfunction deemed to carry inappropriate risk for AHSCT
• Intention or plans for cyclophosphamide mobilization
• Known allergic reactions after previous tetanus diphtheria vaccination or had a condition of Guillain Barre syndrome (GBS)
• Known active hepatitis B, C or human immunodeficiency virus (HIV) infections on initial assessment
• Enrollment on any other transplant related protocols