Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

Observational Study in Patient With Multiple Myeloma Relapse/Refractory Treated With Belantamab Mafotidine on Monotherapy Previously Exposed to at Least One Proteasome Inhibitor, Immunomodulatory Agent, and Anti-CD38 Antibody.

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Belantamab mafodotin

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Clinical Trial Office Clinical Trial Office; Phone Number: +39 011 0243236; Email: clinicaltrialoffice@emnitaly.org

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • Aou Ospedali Riuniti Umberto I
    • Contact: Massimo Offidani
  • Bologna, Italy
    • Recruiting
    • Policlinico Sant'Orsola Malpighi, Aou Di Bologna
    • Contact: Elena Zamagni
  • Brescia, Italy
    • Recruiting
    • A.O. Spedali Civili di Brescia
    • Contact: Angelo Belotti, MD
  • Cagliari, Italy
    • Recruiting
    • Ospedale "A. Businco"
    • Contact: Daniele Derudas
  • Catania, Italy
    • Recruiting
    • AOU Policlinico Vittorio Emanuele
    • Contact: Francesco Di Raimondo
  • Ferrara, Italy
    • Recruiting
    • A.O.U. Arcispedale Sant'Anna
    • Contact: Antonio Cuneo
  • Milano, Italy
    • Recruiting
    • Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
    • Contact: Alessandra Pompa
  • Napoli, Italy
    • Not yet recruiting
    • A.O.U. Federico II
    • Contact: Roberta Della Pepa
  • Palermo, Italy
    • Recruiting
    • La Maddalena S.p.a
    • Contact: Maurizio Musso
  • Roma, Italy
    • Recruiting
    • Policlinico Umberto I - Università La Sapienza
    • Contact: Maria Teresa Petrucci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Belantamab Mafoditin; MMRR patients included in Named Patient Program and Expanded Access Program	Drug: Belantamab mafodotin; MMRR patients included in Named Patient Program e Expanded Access Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best response or minimal response	percentage of patients that achieved a clinical benefit	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione EMN Italy Onlus
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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. Erratum In: Leukemia. 2012 May;26(5):1153. Nari, Hareth [corrected to Nahi, Hareth].
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: EAP; Mulitple Myeloma; Belantamab Mafoditin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: REAL-BELAMAF-ITALY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No