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

Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:Any
Start Date:March 2008
Contact:Susan Carpenter, PhD

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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.

Inclusion Criteria:

- Relapsed or refractory multiple myeloma treated with at least 1 and not more than 3
prior regimens. 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.

- Monoclonal protein in the serum of ≥ 1 g/dL (10 g/L) or monoclonal light chain in the
urine protein electrophoresis of ≥ 200 mg/24 hours, involved SFLC level ≥ 10 mg/dL
(100 mg/L) provided SFLC ratio is abnormal, or 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 ≥ 75,000/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 ≤ 1.7 x ULN

- 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.
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Los Angeles, California 90095
(310) 825-4321
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Emile St
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(402) 559-4000
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333 Cottman Ave
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(215) 728-6900
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