Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy

Multiple Myeloma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393024
• Other study ID #: REAL-BELAMAF-ITALY
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Fondazione EMN Italy Onlus
• Contact: Clinical Trial Office Clinical Trial Office
• Phone: +39 011 0243236
• Email: clinicaltrialoffice[@]emnitaly.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Belantamab mafodotin
MMRR patients included in Named Patient Program e Expanded Access Program

Locations

Country	Name	City	State
Italy	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	Milano
Italy	A.O.U. Federico II	Napoli
Italy	La Maddalena S.p.a	Palermo
Italy	Policlinico Umberto I - Università La Sapienza	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione EMN Italy Onlus

Country where clinical trial is conducted

Italy, 

References & 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, — View Citation

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, Vo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best response or minimal response	percentage of patients that achieved a clinical benefit	1 year
Secondary	Overall Response Rate (ORR)	percertange of patient with confirmed partial response	1 year
Secondary	Progression Free Survival (PFS)	time from the first Belantamab Mafodotin administration until disease progression	1 year
Secondary	Duration of Response (DoR)	time for first documentated partial or best response until disease progression	1 year
Secondary	Overall Survival	time from starting of treatment until death or other cause	1 year