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Trial record 1 of 372 for:    LENALIDOMIDE AND Dexamethasone
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Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01861340
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Myeloma Drug: Lenalidomide, Dexamethasone, and MEDI-551 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.
Actual Study Start Date : May 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: 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.
Drug: Lenalidomide, 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.




Primary Outcome Measures :
  1. The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. The safety of Medi-551 when combined with Lenalidomide and dexamethasone. [ Time Frame: 28 weeks ]

Other Outcome Measures:
  1. The pharmacodynamics (reduction in B cells) of this combination [ Time Frame: 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861340


Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
MedImmune LLC
Investigators
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Principal Investigator: Carol Ann Huff, MD The Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01861340     History of Changes
Other Study ID Numbers: J1340
NA_00081182 ( Other Identifier: Johns Hopkins )
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors