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A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Applied Molecular Evolution.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Applied Molecular Evolution
ClinicalTrials.gov Identifier:
NCT00689507
First received: May 29, 2008
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Relapsed or Refractory Multiple Myeloma
Biological: LY2127399
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Applied Molecular Evolution:

Primary Outcome Measures:
  • Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and toxicity profile for LY2127399 in combination with bortezomib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Response rate, duration of response, and time to progression of LY2127399 as a single-agent [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: LY2127399
    Dose Escalation Phase(Part A): 1, 10, 30, 100, or 300 mg 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 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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00689507

Locations
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
Study Director: Susan Carpenter, PhD Applied Molecular Evolution
  More Information

No publications provided

Responsible Party: Applied Molecular Evolution
ClinicalTrials.gov Identifier: NCT00689507     History of Changes
Other Study ID Numbers: H9S-MC-JDCF(d)
Study First Received: May 29, 2008
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Applied Molecular Evolution:
Multiple Myeloma
Relapsed
Refractory
Bortezomib
Velcade

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014