Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

NCT05393024 | Completed

• 1 other identifier: REAL-BELAMAF-ITALY
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 10

Brief Summary

This is a retrospective/prospective observational study evaluating the efficacy and safety of Belantamab Mafotidin as a single agent in patients with Multiple Myeloma Relapse/Refractory (MMRR) treated in clinical pratice under compassionate use

Conditions

Multiple Myeloma

Keywords

Mulitple Myeloma; Belantamab Mafoditin; EAP

Outcome Measures

Primary Outcomes (1)

• Best response or minimal response

  percentage of patients that achieved a clinical benefit

  1 year

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  1 year

• Progression Free Survival (PFS)

  1 year

• Duration of Response (DoR)

  1 year

• Overall Survival

  1 year

Study Arms (1)

Belantamab Mafoditin

MMRR patients included in Named Patient Program and Expanded Access Program

Drug: Belantamab mafodotin

Interventions

Belantamab mafodotin DRUG

MMRR patients included in Named Patient Program e Expanded Access Program

Belantamab Mafoditin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients with MMRR previously treated with at least one proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

You may qualify if:

• Written informed consent may be obtained from the patient or legally authorized representative according to local regulations (patients who have already died may also be included)
• Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG criteria of 2016 and:
• patient has undergone stem cells transplantation or is considered ineligible for transplantation, and
• patient has received at least four therapies
• patient is refractory to an anti-CD38 antibody (ex., daratumumab) alone or in combination, and to an IMiD (ex., lenalidomide or pomalidomide), and to a proteasome inhibitor (ex. bortezomib, ixazomib or carfilzomib).
• Male or female equal and/or upper 18 years (at baseline)
• Performance Status at baseline by ECOG scale 0-2
• Adequate organ system functions at baseline
• Female patients: a female patient is elegible if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• She is/was not a woman of childbearing potential (WOCBP) OR
• She is/was using an highly effective contrapcetive method during the treatment period and at least 9 months after the last dose and she agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
• Highly sensitive negative serum pregnancy test within 72 hours of therapy (C1D1) and agreed to use effective contraception during the treatment period and for the next 9 months after the last dose of the drug.
• Male patient: male patient were/are elegible if agreed to follow from the first dose until the last dose of treatment to allow clearance of any altered sperm:
• abstaining from sperm donation PLUS
• abstaing from heterosexual relationship in accordance with one's preferred and habitual lifestyle (long-term and persistent abstinent) and agreed/accepted to remain abstinent OR

You may not qualify if:

• The patients are/were not elegible for compassionate use programs (NPP, EAP)

Sponsors & Collaborators

• Fondazione EMN Italy Onlus: lead

Study Sites (10)

AOU Ospedali Riuniti Umberto I

Ancona, Italy

Location

Policlinico Sant'Orsola Malpighi, Aou Di Bologna

Bologna, Italy

Location

A.O. Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale "A. Businco"

Cagliari, Italy

Location

AOU Policlinico Vittorio Emanuele

Catania, Italy

Location

A.O.U. Arcispedale Sant'Anna

Ferrara, Italy

Location

Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

Milan, Italy

Location

A.O.U. Federico II

Napoli, Italy

Location

La Maddalena S.p.a

Palermo, Italy

Location

Policlinico Umberto I - Università La Sapienza

Roma, Italy

Location

Related Publications (2)

• Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, LeLeu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blade J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29.

  PMID: 21799510 RESULT

• Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

  PMID: 31859245 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Teresa Petrucci, MD

  Policlinico Umberto I - Università 'Sapienza'

  PRINCIPAL INVESTIGATOR

• Massimo Offidani, MD

  A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: July 22, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)