Skip to content

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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221743
Enrollment
Unknown
Registered
2012-03-21
Start date
2012-03-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

investigational material(s) Generic name etc : LY2127399 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * Have relapsed or refractory MM treated with at least 1 prior regimen. * Have measurable disease as defined by one or more of the following -serum M-protein concentration greater than or equal to 1 g/dL (10 g/L) -urine monoclonal light chain concentration greater than or equal to 200 mg/24 hours as determined by urine protein electrophoresis -involved serum free light chain (SFLC) concentration greater than or equal to 10 mg/dL (100 mg/L)and an abnormal SFLC ratio * Have adequate organ function (hematopoietic function, liver function, renal function). * Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of less than or equal to 2.

Exclusion criteria

Exclusion criteria: * Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. * Have known positive test results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * Have greater than or equal to Grade 2 peripheral neuropathy or any grade with pain as assessed using the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v 4.03). * Have previously received an allogenic hematopoietic stem cell transplant. * Have a corrected QT (QTc) interval >470 msec on their baseline electrocardiogram (ECG).

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026