Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

NCT ID: NCT05393024

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2024-08-12

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

Detailed Description

Multiple myeloma (MM) is an incurable disease that accounts for 1% of all cancers and 10% of all haematological malignancies, most patients with MM develop resistance to existing therapies at the time of disease recurrence.

Belantamab mafodotin is a new humanized antibody-drug conjugate (IgG1) that is under development for the treatment of MM and has demonstrated a manageable safety profile and positive clinical activity in patients with relapsed or refractory multiple myeloma (MMRR) heavily pretreated.

The objective of this retro-prospective observational study is: to evaluate clinical efficacy as the percentage of patients who have achieved a clinical benefit (minimum or best response), ORR, DoR, PFS, OS; evaluate the safety profile of patients treated with Belantamab Mafodotin as monotherapy in clinical practice.

All patients included in this analysis were treated or are still receiving Belantamab Mafodotin monotherapy under the compassionate use programs (nominal program-NPP and the extended access program-EAP).

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Belantamab Mafoditin

MMRR patients included in Named Patient Program and Expanded Access Program

Belantamab mafodotin

Intervention Type: DRUG

MMRR patients included in Named Patient Program e Expanded Access Program

Interventions

Belantamab mafodotin

MMRR patients included in Named Patient Program e Expanded Access Program

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG criteria of 2016 and:

1. patient has undergone stem cells transplantation or is considered ineligible for transplantation, and

2. patient has received at least four therapies

3. 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).

3. Male or female equal and/or upper 18 years (at baseline)

4. Performance Status at baseline by ECOG scale 0-2

5. Adequate organ system functions at baseline

6. 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
• agree/agreed to use contraption as described below: agree to use male condom even though they have/had succesfully vasectomy and female partner uses/used an additional highly effective contraceptive method.

7. All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) were Grade 1 or less at t at the time of treatment initiation within compassionate use programs, except alopecia and neuropathy grade 2.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione EMN Italy Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Teresa Petrucci, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Umberto I - Università 'Sapienza'

Massimo Offidani, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

AOU Ospedali Riuniti Umberto I

Ancona, , Italy

Policlinico Sant'Orsola Malpighi, Aou Di Bologna

Bologna, , Italy

A.O. Spedali Civili di Brescia

Brescia, , Italy

Ospedale "A. Businco"

Cagliari, , Italy

AOU Policlinico Vittorio Emanuele

Catania, , Italy

A.O.U. Arcispedale Sant'Anna

Ferrara, , Italy

Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

Milan, , Italy

A.O.U. Federico II

Napoli, , Italy

La Maddalena S.p.a

Palermo, , Italy

Policlinico Umberto I - Università La Sapienza

Roma, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 21799510 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31859245 (View on PubMed)

Other Identifiers

REAL-BELAMAF-ITALY

Identifier Type: -

Identifier Source: org_study_id