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

Phase 1
18 Years
Open (Enrolling)
Relapsed or Refractory Multiple Myeloma

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Susan Carpenter, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Applied Molecular Evolution


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Relapsed
  • Refractory
  • Bortezomib
  • Velcade
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Alabama Birmingham, Alabama  
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Dana Farber Cancer Institute Boston, Massachusetts  02115
UCLA Los Angeles, California  90095