Cellectar Biosciences Announces Clinical Trial For Relapsed/Refractory Myeloma Patients

. "We are excited to be developing a new treatment option for this difficult disease. Because of its unique mechanism of action, I-131-CLR1404 may represent an entirely different treatment approach for patients that are no longer responding to currently available therapies," commented Dr. Natalie Callander, principal investigator of Cellectar's I-131-CLR1404 multiple myeloma trial, Associate Professor of Medicine, and Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program. "I-131-CLR1404 appears to be a promising investigational drug and pre-clinical data indicate that the combination of Cellectar's cancer-selective delivery and retention platform with a known radiotherapeutic could be highly effective in treating multiple myeloma. We look forward to working with Cellectar and other investigators to explore the potential of I-131-CLR1404 as a treatment for relapsed or refractory multiple myeloma." This is a multi-center, open-label, sequential group, dose escalation, Phase I proof-of-concept study evaluating the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in multiple myeloma patients who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor. The secondary objectives of the study are to identify a recommended Phase II dose and assess therapeutic activity of I-131-CLR1404 in relapsed or refractory multiple myeloma. Therapeutic activity will be assessed by overall response rate, time to progression and duration of response. Patients will be enrolled into cohorts that receive escalating single doses of I-131-CLR1404 combined with a set dose of dexamethasone. The first cohort of subjects will receive a 12.5 mCi/m2 dose of I-131-CLR1404. A minimum of three subjects will be enrolled at each dose level. Dose escalation and level expansion will be guided by safety and will be performed after all subjects in a cohort have been followed for 12 weeks. Following identification of the highest tolerated dose, additional I-131-CLR1404-naïve subjects will be enrolled and treated with the identified dose of I-131-CLR1404 without concurrent oral dexamethasone. "I-131-CLR1404 has been generally well tolerated in patients and we believe that its selectivity and potency provide a solid rationale for its use in multiple myeloma," said Dr. Simon Pedder, president and chief executive officer of Cellectar Biosciences. "Based on results from our Phase I trials and the radiosensitivity of multiple myeloma, we believe 12.5 mCi/m2 is a meaningful starting dose of I-131-CLR1404 and evidence of clinical activity will be assessable relatively early in the dose escalation process." Additional information can be found here. Eligibility