Enrollment to cease im­medi­ately; top­line data antic­i­pated in H1 2021

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced pos­i­tive re­sults from a planned interim analysis of the on­go­ing GENESIS Phase 3 trial of motix­a­fortide for stem cell mo­bi­li­za­tion (SCM) in mul­ti­ple myeloma patients.

At a meeting of the study's in­de­pen­dent Data Monitoring Com­mit­tee (DMC), a planned interim analysis of the study's pri­mary end­point was con­ducted in­de­pen­dent­ly by the DMC. Based on the statistically sig­nif­i­cant evi­dence favoring treat­ment with motix­a­fortide, the DMC issued a recom­men­da­tion to the Com­pany that patient …

Interim analysis in GENESIS to be com­pleted in next few months

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced that a suf­fi­cient num­ber of patients (~65% of the original planned sample size) have been en­rolled in the on­go­ing GENESIS Phase 3 trial to allow for an interim ef­fi­cacy analysis to take place in the sec­ond half of 2020. This on­go­ing reg­is­tra­tional study is investigating motix­a­fortide (BL-8040) for the mo­bi­li­za­tion of hema­to­poietic stem cells (HSCs) for au­tol­o­gous trans­plan­ta­tion in patients with mul­ti­ple myeloma. If the pri­mary end­point is met at the …

Data from first lead-in patient cohort prompts Data Monitoring Com­mit­tee to rec­om­mend early con­tin­u­a­tion to ran­dom­ized placebo-controlled part 2 of trial

Tel Aviv, Israel (Press Release) – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy and immunology, an­nounced to­day pos­i­tive re­sults from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial com­par­ing BL-8040 in com­bi­na­tion with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobili­za­tion of hema­to­poietic stem cells (HSCs) used for au­tol­o­gous trans­plan­ta­tion in mul­ti­ple myeloma patients.

The open-label, single-arm, lead-in period of the study was de­signed to in­clude up to 30 patients, with Data Monitoring Com­mit­tee (DMC) re­view after com­ple­tion of …

In September 2015, after three months of induction with Revlimid (lena­lidomide), Velcade (bortezomib), and dexamethasone (Decadron), my IgA heavy chain M-spike had fallen from 6.5 g/dL (65 g/L) to zero. My doctor felt that the time was right to get onto the next phase of treatment – a stem cell transplant.

I remember being apprehensive, but actually quite excited at the same time, as this procedure seemed to be the door to a real chance of re­mission and – with luck – many years of good health …

How has your week been, myeloma world?

Summer definitely is here at Myeloma Morning Headquarters. We had temper­a­tures yesterday and today that rival those normally seen in early August.

We're not exactly sure how we feel about this devel­op­ment.

As for myeloma-related news, we have a lot of ground to cover.

We have one new myeloma research study that we summarize at length. It's about a difficult subject, namely, the impact of early relapse on the over­all survival of multiple myeloma patients. It's a difficult subject be­cause, not surprisingly, early re­lapse con­tinues …

Good morning, myeloma world.

We've got a lot of new myeloma-related research to cover today, so we'll get right down to business.

The first two studies we will review are related to autologous (own) stem cell transplantation.

One study looks at whether myeloma cells make their way into the infusion of a patient's own stem cells that a patient gets during the autologous transplant process. The study finds that, in some cases, myeloma cells do make it into the stem cell infusion, and when this happens, it could – again, could – …