Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Overview

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.
SparkCures ID 369
Trial Phase Pilot Trial
Enrollment 15 Patients
Treatments
Trial Sponsors
  • Sidney Kimmel Comprehensive Cancer Center
Trial Collaborators
  • MedImmune
NCT Identifier

NCT01861340

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.
  • 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 ULN
  • AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA 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 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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