A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of AMG 397 in Subjects With Multiple Myeloma, NHL, and AML


About this study

The purpose of this study is to evaluate the safety and tolerability of AMG 397 by estimating the maximum tolerated doses (MTDs) and/or biologically active doses.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Age ≥ 18 years old.
  • Pathologically-documented, definitively-diagnosed relapsed or refractory MM, NHL, or AML and is intolerant to, or considered ineligible for available therapies known to provide clinical benefit. 
  • MM subjects only: Measurable disease per the IMWG response criteria, as indicated by one or more of the following:
    • Serum M-protein ≥ 0.5 g/dL, Urine M-protein ≥ 200 mg/24 hours.
    • For Subjects who do not meet 1 of the 2 prior criteria:
      • Serum Free Light Chain (sFLC) ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal sFLC ratio (< 0.26 or > 1.65) as per the IMWG response criteria. 
  • NHL subjects only: Radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension.
  • AML subjects only: Pathologically confirmed diagnosis of AML as defined by the WHO Classification, More than 5% blasts in bone marrow.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption. 
  • Hepatic function, as follows: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN), Total bilirubin (TBIL) < 1.5 X ULN (except subjects with Gilbert's syndrome).
  • Cardiac function, as follows: Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by an ECHO or MUGA, No clinically significant ECG findings.
  • Renal function as follows: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault [(140 - Age) × Mass (kg) / (72 × serum creatinine mg/dL)]. Multiply result by 0.85 if female.

Exclusion Criteria: 

  • Previously received an allogeneic stem cell transplant within 6 months of study day 1 OR having signs or symptoms of acute or chronic graft-versus-host disease. 
  • Autologous stem cell transplant < 90 days prior to study day 1. 
  • Candidates for stem cell transplant should have failed or are not considered eligible for either allogeneic and autologous transplant. 
  • Myocardial infarction within 6 months of study day 1. 
  • Symptomatic congestive heart failure (New York Heart Association > Class II).
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months prior to study day 1.
  • Infection requiring intravenous anti-infective treatments within 1 week of study day 1.
  • Known positive results for human immunodeficiency virus (HIV). 
  • Active hepatitis B and C based on the following results:
    • Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic, hepatitis B or recent acute hepatitis B), Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
  • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria with the exception of grade 2peripheral neuropathy, alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 4 weeks prior to study day 1 may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor).
  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent or procedures) within 14 days of day 1. 
  • Prior systemic radiation therapy must have been completed at least 28 days before study day 1. Prior focal radiotherapy completed at 14 days before study day 1. 
  • Males and females of reproductive potential who are unwilling to practice an acceptable method(s) of effective birth control while on study through 3 months after receiving the last dose of study drug. Acceptable methods of effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with barrier methods (diaphragm, cervical cap, or cervical sponge), hormonal birth control or IUD (females). 
  • Females who are lactating/breastfeeding or who plan to breastfeed while on study through 3 months after receiving the last dose of study drug. 
  • Females with a positive pregnancy test or planning to become pregnant while on study through 3 months after receiving the last dose of study drug. 
  • Males who are unwilling to abstain from sperm donation while on study through 3 months after receiving the last dose of study drug.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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