Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Belantamab mafodotin

• Registration Number: NCT05393024
• Lead Sponsor: Fondazione EMN Italy Onlus

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).

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Study Start: 2022-07-22
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Belantamab Mafoditin	Belantamab mafodotin	MMRR patients included in Named Patient Program and Expanded Access Program

Primary Outcome Measures

Name	Time	Method
Best response or minimal response	1 year	percentage of patients that achieved a clinical benefit

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1 year	percertange of patient with confirmed partial response
Duration of Response (DoR)	1 year	time for first documentated partial or best response until disease progression
Progression Free Survival (PFS)	1 year	time from the first Belantamab Mafodotin administration until disease progression
Overall Survival	1 year	time from starting of treatment until death or other cause

Trial Locations

Locations (10)

AOU Ospedali Riuniti Umberto I; 🇮🇹 Ancona, Italy

A.O.U. Arcispedale Sant'Anna; 🇮🇹 Ferrara, Italy

A.O.U. Federico II; 🇮🇹 Napoli, Italy

Policlinico Umberto I - Università La Sapienza; 🇮🇹 Roma, Italy

A.O. Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

AOU Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Policlinico Sant'Orsola Malpighi, Aou Di Bologna; 🇮🇹 Bologna, Italy

Ospedale "A. Businco"; 🇮🇹 Cagliari, Italy

La Maddalena S.p.a; 🇮🇹 Palermo, Italy