A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors

Exclusion criteria

• . Massive bone marrow infiltration on the baseline 68Ga-DOTATATE PET/CT scan
• . History of hypersensitivity or allergy to 225Ac, 68Ga, octreotate, or any of the excipients of DOTATATE imaging agents
• . Use of anticancer agents within the following intervals prior to the first dose of study drug:
• . Prior external beam radiotherapy on more than 25% of bone marrow
• . Prior participation in any interventional clinical study within 30 days prior to first dose of study drug
• . Have a history of primary malignancy within the past 3 years other than (1) MM; (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin; (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject's survival status for ≥3 years based on clinician assessment/statement
• . Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1 at baseline, except for alopecia
• . Significant cardiovascular disease, defined as: