Patricia Inácio, PhD, science writer —

A study is recruiting participants to examine the molecular changes that occur when precursor conditions develop into full-blown multiple myeloma, information that can then be used to design therapies to halt disease progression. The PROMISE study is open to adults living in the U.S., ages 45 to 75 years, who are African-American…

Janssen Pharmaceutical has submitted an application to Japanese authorities requesting that Darzalex (daratumumab) be approved, in combination with standard therapy, to treat newly diagnosed multiple myeloma patients who cannot receive a stem cell transplant. The supplemental new drug application (sNDA), which will be considered under a priority review, is based on data from…

Early treatment with a triple combination therapy containing Empliciti (elotuzumab), Revlimid (lenalidomide), and dexamethasone in patients with smoldering multiple myeloma — a precursor of multiple myeloma — may halt the disease’s progression into the full-blown condition, a Phase 2 trial shows. The results were presented at the American Society…

An international Phase 2 trial testing the investigational CAR T-cell therapy bb2121 for the treatment of relapsed or refractory multiple myeloma patients has completed patient recruitment, Celgene and bluebird bio announced. The KarMMa trial (NCT03361748) included 140 patients across the U.S., Canada, and Europe, who had received at least three…

The U.S. Food and Drug Administration has allowed Fortis Therapeutics’ antibody-drug conjugate FOR46 to begin testing in a Phase 1 clinical trial as a therapy for late-stage multiple myeloma. The trial (NCT03650491), scheduled to begin in early 2019, estimates to enroll 50 myeloma patients who have failed prior…

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb‘s Empliciti (elotuzumab), in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, as a treatment for patients with relapsed or treatment-resistant multiple myeloma. The approval covers patients whose disease progressed despite treatment with at least two therapies, including Celgene‘s Revlimid (lenalidomide) and…

Myeloma Crowd has launched an online tool called HealthTree, aimed at helping patients with multiple myeloma find the most appropriate therapies for their condition, while boosting research toward a potential cure for multiple myeloma. By registering with HealthTree, which is free, patients can track their body’s response to different…

Amgen is seeking to expand the approval of its proteasome inhibitor Kyprolis (carfilzomib) in the U.S. to include once-weekly dosing combined with dexamethasone for multiple myeloma patients with hard-to-treat disease or whose disease relapsed. The company used data from its Phase 3 ARROW trial as the basis for its…

The U.S. Food and Drug Administration granted priority review to Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) combined with Pomalyst (pomalidomide) and low-dose dexamethasone as a treatment for patients with relapsed or treatment-resistant multiple myeloma. The application covers patients whose disease has progressed despite treatment with at least two…

The U.S. Food and Drug Administration has granted orphan drug status to SRF231 to treat multiple myeloma, according to Surface Oncology, which is developing the investigational therapy. Orphan drug designation aims to assist in developing therapies for rare and serious diseases that have a high unmet need by providing…