American Association for Cancer Research
10780432ccr190647-sup-217699_3_supp_5754423_pxbjrg.png (154.06 kB)

Supplementary Data 1 from A Phase Ib/II Trial of the First-in-Class Anti-CXCR4 Antibody Ulocuplumab in Combination with Lenalidomide or Bortezomib Plus Dexamethasone in Relapsed Multiple Myeloma

Download (154.06 kB)
posted on 2023-03-31, 21:27 authored by Irene M. Ghobrial, Chia-Jen Liu, Robert A. Redd, Raymond P. Perez, Rachid Baz, Oksana Zavidij, Romanos Sklavenitis-Pistofidis, Paul G. Richardson, Kenneth C. Anderson, Jacob Laubach, Patrick Henrick, Alexandra Savell, Kaitlen Reyes, Kalvis Hornburg, Stacey Chuma, Peter Sabbatini, Michael D. Robbins, Pamela S. Becker

This figure presents a consort diagram showing (A) the dose-escalation scheme for BMS-936564 (ulocuplumab), (B) the dose-expansion scheme, including Arms A & B, of the study and (C) Number of patients at each dose level in the phase I and II studies and in arms A and B.


Bristol-Myers Squibb


Leukemia and Lymphoma Society

Multiple Myeloma Research Foundation



Ulocuplumab (BMS-936564) is a first-in-class fully human IgG4 monoclonal anti-CXCR4 antibody that inhibits the binding of CXCR4 to CXCL12. This phase Ib/II study aimed to determine the safety and tolerability of ulocuplumab alone and in combination with lenalidomide and dexamethasone (Arm A), or bortezomib and dexamethasone (Arm B), in patients with relapsed/refractory multiple myeloma. Forty-six patients were evaluated (median age, 60 years; range, 53–67). The median number of prior therapies was 3 (range, 1–11), with 70% of subjects having received ≥3. This trial had a dose-escalation and a dose-expansion part. Using a 3+3 design on both arms of the trial, ulocuplumab's dose was escalated to a maximum of 10 mg/kg without reaching MTD. The most common treatment-related adverse events (AE) were neutropenia (13 patients, 43.3%) in Arm A and thrombocytopenia (6 patients, 37.5%) in Arm B. No deaths related to study drugs occurred. The combination of ulocuplumab with lenalidomide and dexamethasone showed a high response rate (PR or better) of 55.2% and a clinical benefit rate of 72.4%, even in patients who had been previously treated with immunomodulatory agents (IMiD). This study showed that blockade of the CXCR4–CXCL12 axis by ulocuplumab is safe with acceptable AEs and leads to a high response rate in combination with lenalidomide and dexamethasone in patients with relapsed/refractory myeloma, making CXCR4 inhibitors a promising class of antimyeloma drugs that should be further explored in clinical trials.

Usage metrics

    Clinical Cancer Research



    Ref. manager