Patricia Inácio, PhD, science writer —

Cellectis announced plans to open a Phase 1 clinical trial to evaluate UCARTCS1 — its first allogeneic (donor-derived) CAR T-cell therapy for multiple myeloma patients — at several sites in the U.S. The trial, called MUNDI-01, will assess multiple doses of the therapy to determine its safety, cell expansion and persistence,…

Janssen Biotech is planning a new Phase 3 clinical trial to explore a combination of under-the-skin daratumumab plus Revlimid (lenalidomide) as a maintenance treatment for multiple myeloma patients who received an autologous stem cell transplant as front-line treatment. Specifically, the study is for patients who are positive for minimal…

Janssen has submitted an application to Japanese authorities seeking the approval of Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and dexamethasone — for the treatment of newly diagnosed multiple myeloma patients ineligible for high-dose chemotherapy and stem cell transplant. The supplemental new drug application, which will be considered under priority review, is based on…

NantKwest and ProMab Biotechnologies are collaborating to develop a novel immunotherapy for multiple myeloma using natural killer (NK) cells that target the B-cell maturation antigen, or BCMA. The therapy, called chimeric antigen receptor (CAR) NK-cell, is a tweaked version of the conventional CAR-T cell therapy: instead of isolating…

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…