Multiple MyelomaNCT05393024
Patient With MMRR Treated With Belantamab Mafotidine on Monotherapy
An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 10 sites in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Belantamab mafodotin
- How many people
- 78 participants
- Where
- 10 sitesItaly
- Study dates
- 22 Jul 2022to 12 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with MMRR previously treated with at least one proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Who may be able to join
- 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)
Show all 17Show fewer
- 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
- 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.
- 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.
Who cannot join
- The patients are/were not elegible for compassionate use programs (NPP, EAP)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
AOU Ospedali Riuniti Umberto I
Ancona
Policlinico Sant'Orsola Malpighi, Aou Di Bologna
Bologna
A.O. Spedali Civili di Brescia
Brescia
Ospedale "A. Businco"
Cagliari
AOU Policlinico Vittorio Emanuele
Catania
A.O.U. Arcispedale Sant'Anna
Ferrara
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
Milan
A.O.U. Federico II
Naples
La Maddalena S.p.a
Palermo
Policlinico Umberto I - Università La Sapienza
Roma
About this study
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.
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
Read the 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
- Being tested
- Belantamab mafodotin
- Keywords
- Mulitple Myeloma, Belantamab Mafoditin, EAP
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab mafodotinDrug
MMRR patients included in Named Patient Program e Expanded Access Program
| Study group | Role | What they receive |
|---|---|---|
| Belantamab Mafoditin | MMRR patients included in Named Patient Program and Expanded Access Program Receives: Drug: Belantamab mafodotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best response or minimal response
percentage of patients that achieved a clinical benefit
Measured: 1 year
Secondary outcomes (4)
Overall Response Rate (ORR)
percertange of patient with confirmed partial response
Measured: 1 year
Progression Free Survival (PFS)
time from the first Belantamab Mafodotin administration until disease progression
Measured: 1 year
Duration of Response (DoR)
time for first documentated partial or best response until disease progression
Measured: 1 year
Overall Survival
time from starting of treatment until death or other cause
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start22 Jul 2022
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Teresa Petrucci, MD, Principal investigator, Policlinico Umberto I - Università 'Sapienza'Massimo Offidani, MD, Principal investigator, A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393024
- Sponsor's protocol ID
- REAL-BELAMAF-ITALY
- Status last verified
- Jan 2025
- First submitted
- 23 May 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21799510Lonial 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.
PubMed 31859245
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05393024
- Acronym / sponsor ID
- REAL-BELAMAF-ITALY
- Conditions
- Multiple Myeloma
- Keywords
- Mulitple Myeloma, Belantamab Mafoditin, EAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belantamab Mafoditin | – | Drug: Belantamab mafodotinMMRR patients included in Named Patient Program and Expanded Access Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with MMRR previously treated with at least one proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (1 listed)
- The patients are/were not elegible for compassionate use programs (NPP, EAP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinMMRR patients included in Named Patient Program e Expanded Access Program | Drug | Belantamab Mafoditin |
Primary outcome
Best response or minimal response
Time frame: 1 year
percentage of patients that achieved a clinical benefit
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 year
Progression Free Survival (PFS)
Time frame: 1 year
Duration of Response (DoR)
Time frame: 1 year
Overall Survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Results publication: PubMed 21799510Kumar 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.
- Results publication: PubMed 31859245Lonial 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Teresa Petrucci, MD principal investigator
Policlinico Umberto I - Università 'Sapienza'
Massimo Offidani, MD principal investigator
A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Fondazione EMN Italy Onlus at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best response or minimal response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.