Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

Inclusion criteria

• Age ≥18 years, including males and females;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
• Life expectancy of ≥3 months;
• Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
• For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
• Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
• Ability to swallow oral medications;
• Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion criteria

• Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
• Known impaired cardiac function or clinically significant cardiac disease
• HIV infection;
• Failed to recover from the reversible effects of prior anticancer therapies:
• Pregnancy (positive serum or urine pregnancy test) or breast feeding;
• Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;