Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
Early Phase 1
Completed
- Conditions
- Myeloma
- Interventions
- Drug: Lenalidomide, Dexamethasone, and MEDI-551
- Registration Number
- NCT01861340
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide, Dexamethasone, and MEDI-551 Lenalidomide, Dexamethasone, and MEDI-551 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.
- Primary Outcome Measures
Name Time Method The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). 16 weeks
- Secondary Outcome Measures
Name Time Method The safety of Medi-551 when combined with Lenalidomide and dexamethasone. 28 weeks
Trial Locations
- Locations (1)
The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States