JPRN-jRCT2080224749
Completed
Phase 1
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen K.K.
- Enrollment
- 175
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 75age old (—)
- Sex
- All
Inclusion Criteria
- •1\. Age \>\= 18 years old
- •2\. (Multiple myeloma \[MM] participants) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
- •3\. (MM participants only) Measurable disease per the International Myeloma Working Group response criteria
- •4\. (Acute myeloid leukemia \[AML] participants) AML as defined by the World Health Organization Classification persisting or recurring following one or more treatment courses; and for participants in Japan, determined by the investigator to be not eligible for approved anticancer drug therapy in Japan; EXCEPT acute promyelocytic leukemia.
- •5\. (AML participants only) More than 5% blasts in bone marrow and Circulating white blood cells \< 25,000/ul.
- •6\. Must be willing and able to undergo a core bone marrow biopsy (MM participants only) and bone marrow aspirate (MM and AML participants) at screening.
- •7\. Eastern Cooperative Oncology Group (ECOG) performance status of \<\= 2\.
- •8\. (MM participants only) Satisfactory hematological function without transfusion or growth factor support
- •9\. Life expectancy of \> 3 months, in the opinion of the investigator
- •10\. Adequate hepatic function
Exclusion Criteria
- •1\. Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft\-versus\-host disease
- •2\. Autologous stem cell transplant less than 90 days prior to study day 1
- •3\. (MM participants only) MM with Immunoglobulin M subtype
- •4\. (MM participants only) Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes syndrome
- •5\. (MM participants only) Existing plasma cell leukemia
- •6\. (MM participants only) Waldenstrom's macroglobulinemia
- •7\. (MM participants only) Amyloidosis
- •8\. Infection requiring intravenous anti\-infective treatments within 1 week of study enrollment (day 1\)
- •9\. Myocardial infarction within 6 months of enrollment, symptomatic congestive heart failure (New York Heart Association \> class II)
- •10\. History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 Months prior to enrollment
Investigators
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