Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A nationwide phase 2 trial of patients with smoldering and active multiple myeloma (MM)

Prior treatment

• Diagnosed or treated for another malignancy ≤ 2 years before trial enrollment or previously diagnosed with another malignancy and have any evidence of residual disease
• Other concurrent chemotherapy, or any ancillary therapy considered investigational
• Peripheral neuropathy > Grade 3 on clinical examination or grade 2 with pain within 30 days prior to C1D1
• Major surgery ≤14 days prior to C1D1

Other illness

• Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
• Any medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
• Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products
• Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
• Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
• Known human immunodeficiency virus (HIV) positive

Other

• MGUS or low risk smoldering myeloma
• Inability to comply with protocol/procedures
• Pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception

• Active MM or SMM which is untreated
• Willing to follow strict birth control measures as outlined in the protocol
• Patients must be willing and able to adhere to the study schedule and other protocol requirement
• At least 18 years of age, with at least 6 months of expected survival
• Active MM or SMM (defined as measurable M spike OR pathological FLC ratio AND bone marrow PC% > 10%) which is untreated
• Laboratory values, see protocol
• Prior therapy for the treatment of solitary plasmacytoma is permitted, but >7 days should have elapsed from the last day of radiation.
• Measurable disease as defined by at least ONE of the following: Serum monoclonal protein >1.0 g/L, >200 mg of monoclonal protein in the urine on 24 hour electrophoresis , Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• ECOG performance status (PS) 0, 1 or 2
• Provide informed written consent
• Negative pregnancy test done ≤7 days prior to entry, for women of childbearing potential only