Myeloma
Conditions
Brief summary
This research study is being done to see if combining the investigational chemotherapy drug, MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your myeloma cancer stem cells.
Detailed description
To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.
Interventions
DRUGLenalidomide, Dexamethasone, and MEDI-551
Patients will receive Lenalidomide and dexamethasone as per standard of care. Patients with a clinical response after 2 cycles will get 2 cycles of MEDI-551.
Sponsors
MedImmune LLC
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 100 years at the time screening * Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma * Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations * Patient must agree to take Lenalidomide with low dose dexamethasone as their initial therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Life expectancy of \>6 months * Serum creatinine ≤ 2 * ANC≥1000 * Platelets ≥ 50,000 * Total bilirubin ≤ 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN * Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
Exclusion criteria
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results. * Concurrent enrollment in another clinical study, except for non-interventional, observational studies. * Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than Lenalidomide and dexamethasone. * Previous monoclonal antibody (mAb) or other treatment specifically directed against cluster of differentiation antigen 19 (CD19). * History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration. * Previous systemic cancer therapy for myeloma. * Any active secondary malignancy. * Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency syndrome. * Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or patients with positive hepatitis B core antibody titers. * Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis. * Documented current central nervous system involvement by multiple myeloma. * Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study. * Diagnosis of plasma cell leukemia * Diagnosis of POEMS syndrome * Diagnosis of Amyloidosis * Diagnosis of non-secretory myeloma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The safety of Medi-551 when combined with Lenalidomide and dexamethasone. | 28 weeks |
Other
| Measure | Time frame |
|---|---|
| The pharmacodynamics (reduction in B cells) of this combination | 28 weeks |
Countries
United States
Outcome results
None listed