Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.

Conditions
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Myeloma

Intervention / Treatment
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* Drug: Lenalidomide, Dexamethasone, and MEDI-551


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide, Dexamethasone, and MEDI-551<br>Eligible patients will receive Lenalidomide and dexamethasone as per standard of care guidelines for 2 cycles. Patients with a clinical response to lenalidomide and dexamethasone after 2 cycles will proceed to get MEDI-551 for 2 cycles. MEDI-551 will be dosed at 4mg/kg IV on days 1 and 8 of cycle 3 and 4mg/kg IV on day 1 of cycle 4. | Drug: Lenalidomide, Dexamethasone, and MEDI-551<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of Medi-551 when combined with Lenalidomide and dexamethasone. |  | 28 weeks |