Trial record 2 of 8 for:    MEDI551

Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01861340
First received: May 20, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Myeloma
Drug: Lenalidomide, Dexamethasone, and MEDI-551
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of Medi-551 when combined with Lenalidomide and dexamethasone. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The pharmacodynamics (reduction in B cells) of this combination [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861340

Contacts
Contact: Carol Ann Huff, MD 443-287-7104 huffca@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Carol Ann Huff, MD    443-287-7104    huffca@jhmi.edu   
Principal Investigator: Carol Ann Huff, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
MedImmune LLC
Investigators
Principal Investigator: Carol Ann Huff, MD The Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01861340     History of Changes
Other Study ID Numbers: J1340, NA_00081182
Study First Received: May 20, 2013
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 30, 2014