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A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00689507
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Applied Molecular Evolution

Brief Summary:
H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: LY2127399 Phase 1

Detailed Description:
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : March 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Dose Escalation Phase(Part A):
1,10, 30, 100 or 300 mg of LY2127399 IV on day 1 of specific 21 day cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each 21 day cycle
Biological: LY2127399
monoclonal antibody

Experimental: Dose Confirmation Phase (Part B1):
Dose determined by PK/PD modeling, LY2127399 IV on day 2 of Cycle 1 and on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of each cycle
Biological: LY2127399
monoclonal antibody

Experimental: Dose Confirmation Phase (Part B2):
Dose determined by PK/PD modeling, LY2127399 IV on day 1 of specific cycles and 1.3 mg/m2 Bortezomib IV on days 1, 4, 8, and 11 of specific cycles
Biological: LY2127399
monoclonal antibody




Primary Outcome Measures :
  1. Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Safety and toxicity profile for LY2127399 in combination with bortezomib [ Time Frame: 2 years ]
  2. Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib [ Time Frame: 2 years ]
  3. Response rate, duration of response, and time to progression of LY2127399 as a single-agent [ Time Frame: 2 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Have relapsed or refractory multiple myeloma treated with at least 1 prior regimen. Prior therapy with bortezomib is allowed if there has been no relapse or progression within 3 months of the last dose of bortezomib, and bortezomib is considered by the treating physician to be a reasonable therapy for the patient.
  • Have measurable disease defined by one or more of the following:

    • Monoclonal protein in the serum of ≥1 g/dL (10 g/L).
    • Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours.
    • Involved Serum Free Light Chain (SFLC) level > 10 mg/dL (100 mg/L) provided SFLC ratio is abnormal.
    • Measurable plasmacytoma.
  • Are ≥ 18 years of age.
  • Have given written informed consent prior to any study-specific procedures
  • Have adequate organ function including:

    • Absolute neutrophil count (ANC) ≥ 1000/microliter
    • Platelet (PLT) count ≥ 50,000/microliter
    • Hemoglobin (Hgb) ≥ 8.0 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (if total is elevated check direct and, if normal, patient is eligible)
    • Aspartate transaminase (AST) ≤ 3 x ULN
    • Creatinine ≤ 3.0 mg/dl.
  • Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale (refer to Attachment JDCF.5).
  • Have discontinued all previous therapies for cancer, including chemotherapy and radiotherapy at least 2 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 4 months following the last dose of study drug.
  • Females with child bearing potential must have had a negative urine or serum pregnancy test ≤ 3 days prior to the first dose of study drug.
  • Have an estimated life expectancy of ≥ 16 weeks.
  • Treatment with prior autologous transplant is permitted. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered one line of treatment with the preceding chemotherapy.

Exclusion Criteria:

  • Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
  • Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
  • Have uncontrolled infection.
  • Females who are pregnant or lactating.
  • Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
  • Have peripheral neuropathy of > Grade 2, or of any grade with pain, as measured by CTCAE v3.0.
  • Previously treated with LY2127399, or have had significant allergy to humanized monoclonal antibodies that, in the opinion of the investigator, poses an increased risk to the patient.
  • Prior allogeneic hematopoietic stem cell transplant.
  • Prior therapy with experimental agents targeting BAFF.
  • Have QTc interval > 450 msec on baseline 12-lead ECG.

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): NCT00689507


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-3300
United States, California
UCLA
Los Angeles, California, United States, 90024
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Applied Molecular Evolution
Eli Lilly and Company
Investigators
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Study Director: Susan Carpenter, PhD Applied Molecular Evolution
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Responsible Party: Applied Molecular Evolution
ClinicalTrials.gov Identifier: NCT00689507    
Other Study ID Numbers: H9S-MC-JDCF
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: May 2015
Keywords provided by Applied Molecular Evolution:
Multiple Myeloma
Relapsed
Refractory
Bortezomib
Velcade
Additional relevant MeSH terms:
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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