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RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMANCT05297240

Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.

An observational study of RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA, run by PETHEMA Foundation at 62 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021. Read more about this study

Who is it for?
Any age
What is being tested?
Belantamab mafodotin
How many people
170 participants
Where
62 sitesSpain
Study dates
24 Mar 2022to Dec 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Every patient receiving at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021 will be included in the study.

Who may be able to join

  • Reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021

Who cannot join

None listed.

Trial locations and contacts

62 sites in 1 country.

Carmen López-Carrero contact

0034 699 835 437

carmen@fundacionpethema.es

Roberto Maldonado contact

0034 683 15 66 87

roberto.maldonado@fundacionpethema.es

62 sites in 1 country

Spain62 sites, 62 recruiting

  • H. Universitario de Albacete

    Albacete

    Juan Ramón Romero Macías

    Juan Ramón Romero Macías

    Recruiting

  • H. Doctor José Molina Orosa

    Arrecife

    Víctor Alfonso Ferrandez

    Víctor Alfonso Ferrandez

    Recruiting

  • H. Ntra. Señora Sonsoles

    Ávila

    Abelardo Bárez

    Abelardo Bárez

    Recruiting

  • H. San Agustín

    Avilés

    Walter Javier Zambrano

    Walter Javier Zambrano

    Recruiting

  • H. Clinic de Barcelona

    Barcelona

    Ana Triguero

    Ana Triguero

    Recruiting

  • H. Moises Broggi

    Barcelona

    María Elena María Elena Cabezudo/Gabriela Bustamante

    María Elena Cabezudo

    Recruiting

  • H. Vall d' Hebron

    Barcelona

    Mercedes Gironella

    Mercedes Gironella

    Recruiting

  • H. Basurto

    Bilbao

    José Antonio Márquez

    José Antonio Márquez

    Recruiting

  • H. Cruces

    Bilbao

    Xavier Martín

    Xavier Martín

    Recruiting

  • H. Calahorra

    Calahorra

    Estefanía Ruiz

    Estefanía Ruiz

    Recruiting

  • H. Reina Sofía

    Córdoba

    Margarita Fernández de la Mata

    Margarita Fernández de la Mata

    Recruiting

  • H. General Elche

    Elche

    Venancio Conesa

    Venancio Conesa

    Recruiting

  • H. Fuenlabrada

    Fuenlabrada

    Amaia López

    Amaia López

    Recruiting

  • H. Galdakao

    Galdakao

    Eukene Gainza

    Eukene Gainza

    Recruiting

  • H. Francisco de Borja

    Gandia

    María Ángeles Ruiz

    María Ángeles Ruiz

    Recruiting

  • ICO Girona

    Girona

    Yolanda González

    Yolanda González

    Recruiting

  • H. Un. Virgen de las Nieves

    Granada

    Esther Clavero

    Esther Clavero

    Recruiting

  • H. Un. Guadalajara

    Guadalajara

    Alejandro Vázquez Ramo

    Alejandro Vázquez Ramo

    Recruiting

  • H. Juan Ramón Jiménez

    Huelva

    Juan Francisco Domínguez

    Juan Francisco Domínguez

    Recruiting

  • H. Universitario de Jaén

    Jaén

    Magdalena Anguita

    Magdalena Anguita

    Recruiting

  • H. Un. Doctor Negrín

    Las Palmas de Gran Canaria

    Alexia Alexia Suarez Cabrera

    Alexia Suarez Cabrera

    Recruiting

  • H. Severo Ochoa

    Leganés

    Rosalía Riaza

    Rosalía Riaza

    Recruiting

  • H. León

    León

    Fernando Escalante

    Fernando Escalante

    Recruiting

  • H. San Pedro

    Logroño

    Montserrat Hernández

    Montserrat Hernández

    Recruiting

  • H. Un. Lucus Augusti

    Lugo

    Esperanza Lavilla

    Esperanza Lavilla

    Recruiting

  • Fundación Jiménez Díaz

    Madrid

    Elena Prieto

    Elena Prieto

    Recruiting

  • H. Gregorio Marañón

    Madrid

    Cristina Encinas

    Cristina Encinas

    Recruiting

  • H. Moncloa

    Madrid

    Concha Alaez Usón

    Concha Alaez Usón

    Recruiting

  • H. Ruber Juan Bravo

    Madrid

    Aranzazu Alonso Alonso

    Aranzazu Alonso Alonso

    Recruiting

  • H. Un. Doce de Octubre

    Madrid

    Joaquin Martínez

    Joaquin Martínez

    Recruiting

  • H. Un. Infanta Sofía

    Madrid

    Eugenio Giménez

    Eugenio Giménez

    Recruiting

  • H. Un. La Paz

    Madrid

    Ana López de la Guía

    Ana López de la Guía

    Recruiting

  • H. Un. La Princesa

    Madrid

    Gonzalo Benzo

    Gonzalo Benzo

    Recruiting

  • H. Un. Puerta del Hierro

    Madrid

    Rafael Ríos Tamayo

    Rafael Ríos Tamayo

    Recruiting

  • H. Un. Quirón Salud

    Madrid

    Carmen Martínez Chamorro

    Carmen Martínez Chamorro

    Recruiting

  • H.M. Sanchinarro

    Madrid

    Laura Llorente

    Laura Llorente

    Recruiting

  • Hospital Clínico San Carlos

    Madrid

    Cristina Pérez

    Cristina Pérez

    Recruiting

  • Hospital Universitario Henares

    Madrid

    Cristina Muñoz

    Cristina Muñoz

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    Maria Jesús Blanchard

    Maria Jesús Blanchard

    Recruiting

  • H. Virgen de la Victoria

    Málaga

    Ricarda García

    Ricarda García

    Recruiting

  • H. Rey Juan Carlos

    Móstoles

    Alberto Eterio Velasco

    Alberto Eterio Velasco

    Recruiting

  • H. Morales Meseguer

    Murcia

    Felipe de Arriba

    Felipe de Arriba

    Recruiting

  • H. Un. Virgen de la Arrixaca

    Murcia

    Valentín Cabañas

    Valentín Cabañas

    Recruiting

  • H. Universitario Central Asturias

    Oviedo

    Ángel Ramirez Payer

    Ángel Ramirez Payer

    Recruiting

  • H. Son Llatzer

    Palma de Mallorca

    Raquel del Campo García

    Raquel del Campo García

    Recruiting

  • H. Un. Son Espases

    Palma de Mallorca

    José María Sánchez Raga

    José María Sánchez Raga

    Recruiting

  • H. Montecelo

    Pontevedra

    Ana Maria Dios Loureiro

    Ana Maria Dios Loureiro

    Recruiting

  • H. Un. Salamanca

    Salamanca

    Ramón García Sanz

    Ramón García Sanz

    Recruiting

  • H. Un. Canarias

    Santa Cruz de Tenerife

    Álvaro Bienert García

    Álvaro Bienert García

    Recruiting

  • H. Un. Marqués de Valdecilla

    Santander

    Maria Aranzazu Bermúdez

    Maria Aranzazu Bermúdez

    Recruiting

  • H. General Segovia

    Segovia

    Aranzazu García

    Aranzazu García

    Recruiting

  • H. Un. Virgen de Valme

    Seville

    Eduardo Ríos

    Eduardo Ríos

    Recruiting

  • H. Virgen del Rocío

    Seville

    Estrella Carrillo

    Estrella Carrillo

    Recruiting

  • H. Mutua Terrasa

    Terrassa

    Josep Maria Martí

    Josep Maria Martí

    Recruiting

  • H. Ntra. Señora del Prado

    Toledo

    María Dolores Martínez Moya

    María Dolores Martínez Moya

    Recruiting

  • H. Un. Torrejón

    Torrejón de Ardoz

    Ana Morales

    Ana Morales

    Recruiting

  • H. Un. Dr. Peset

    Valencia

    Ana García Feria

    Ana García Feria

    Recruiting

  • H. Universitario de la Fe

    Valencia

    Rafael Andreu La Piedra

    Rafael Andreu La Piedra

    Recruiting

  • H. Universitario de Valladolid

    Valladolid

    Alfonso García de Coca

    Alfonso García de Coca

    Recruiting

  • H. Clinico Un. Lozano Blesa

    Zaragoza

    Luis Palomera

    Luis Palomera

    Recruiting

  • H. Miguel Servet

    Zaragoza

    Araceli Rubio

    Araceli Rubio

    Recruiting

  • H. Royo Villanova

    Zaragoza

    Vicente Carrasco

    Vicente Carrasco

    Recruiting

Other trials in Spain

About this study

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

Read the detailed description

The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021.

Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

The study has the following objectives:

Primary objective

  • The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with RRMM.

Secondary objectives:

  • Describe the safety and tolerability of single-agent belantamab mafodotin.
  • The overall incidence of ophthalmologic complications.
  • Estimate duration of response (DOR).
  • Estimate time to response (TTR).
  • Estimate time to next treatment (TTNT).
  • Estimate progression-free survival (PFS) and overall survival (OS).
  • Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2.
Being tested
Belantamab mafodotin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotinDrug

    At least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    The percentage of participants with the best overall confirmed response: partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).

    per International Myeloma Working Group (IMWG) uniform response criteria.

    Measured: Throughout the study period. Approximately 3 years

Secondary outcomes (8)

  1. Incidence of treatment-emergent adverse events (AEs)

    Number and percentage of treatment-emergent adverse events (AEs)

    Measured: Throughout the study period. Approximately 3 years

  2. Incidence of ocular events

    Number and percentage of ocular events

    Measured: Throughout the study period. Approximately 3 years

  3. Duration of response (DOR)

    The time from first date of PR or better to date of disease progression or death due to any cause.

    Measured: Throughout the study period. Approximately 3 years

  4. Time to response (TTR)

    The time from date of first dose of belantamab mafodotin to date of first occurrence of response.

    Measured: Throughout the study period. Approximately 3 years

  5. Time to next treatment (TTNT).

    The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment.

    Measured: Throughout the study period. Approximately 3 years

  6. Progression free survival (PFS)

    The time from start of treatment until progression or death from any cause

    Measured: Throughout the study period. Approximately 3 years

  7. Overall survival (OS)

    The time from start of treatment until death from any cause.

    Measured: Throughout the study period. Approximately 3 years

  8. Second progression free survival (PFS2)

    The time from start of belantamab mafodotin to progression on next-line treatment, or death from any cause, whichever is earlier; otherwise censored at the last time known to be alive and without second objective disease progression.

    Measured: Throughout the study period. Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297240
Sponsor's protocol ID
GEM-RELAMAB
Status last verified
Aug 2022
First submitted
17 Mar 2022
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.

    PubMed 21410373

  • Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.

    PubMed 24157580

  • Zanwar S, Abeykoon JP, Kapoor P. Challenges and Strategies in the Management of Multiple Myeloma in the Elderly Population. Curr Hematol Malig Rep. 2019 Apr;14(2):70-82. doi: 10.1007/s11899-019-00500-4.

    PubMed 30820879

  • Kumar SK, Callander NS, Hillengass J, Liedtke M, Baljevic M, Campagnaro E, Castillo JJ, Chandler JC, Cornell RF, Costello C, Efebera Y, Faiman M, Garfall A, Godby K, Holmberg L, Htut M, Huff CA, Kang Y, Landgren O, Malek E, Martin T, Omel J, Raje N, Sborov D, Singhal S, Stockerl-Goldstein K, Tan C, Weber D, Johnson-Chilla A, Keller J, Kumar R. NCCN Guidelines Insights: Multiple Myeloma, Version 1.2020. J Natl Compr Canc Netw. 2019 Oct 1;17(10):1154-1165. doi: 10.6004/jnccn.2019.0049.

    PubMed 31590151

  • Hoyos V, Borrello I. The immunotherapy era of myeloma: monoclonal antibodies, vaccines, and adoptive T-cell therapies. Blood. 2016 Sep 29;128(13):1679-87. doi: 10.1182/blood-2016-05-636357. Epub 2016 Aug 9.

    PubMed 27506540

  • Rickert RC, Jellusova J, Miletic AV. Signaling by the tumor necrosis factor receptor superfamily in B-cell biology and disease. Immunol Rev. 2011 Nov;244(1):115-33. doi: 10.1111/j.1600-065X.2011.01067.x.

    PubMed 22017435

  • Frigyesi I, Adolfsson J, Ali M, Christophersen MK, Johnsson E, Turesson I, Gullberg U, Hansson M, Nilsson B. Robust isolation of malignant plasma cells in multiple myeloma. Blood. 2014 Feb 27;123(9):1336-40. doi: 10.1182/blood-2013-09-529800. Epub 2014 Jan 2.

    PubMed 24385542

  • Tai YT, Mayes PA, Acharya C, Zhong MY, Cea M, Cagnetta A, Craigen J, Yates J, Gliddon L, Fieles W, Hoang B, Tunstead J, Christie AL, Kung AL, Richardson P, Munshi NC, Anderson KC. Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma. Blood. 2014 May 15;123(20):3128-38. doi: 10.1182/blood-2013-10-535088. Epub 2014 Feb 25.

    PubMed 24569262

  • Seckinger A, Delgado JA, Moser S, Moreno L, Neuber B, Grab A, Lipp S, Merino J, Prosper F, Emde M, Delon C, Latzko M, Gianotti R, Luoend R, Murr R, Hosse RJ, Harnisch LJ, Bacac M, Fauti T, Klein C, Zabaleta A, Hillengass J, Cavalcanti-Adam EA, Ho AD, Hundemer M, San Miguel JF, Strein K, Umana P, Hose D, Paiva B, Vu MD. Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment. Cancer Cell. 2017 Mar 13;31(3):396-410. doi: 10.1016/j.ccell.2017.02.002. Epub 2017 Mar 2.

    PubMed 28262554

  • Moreaux J, Legouffe E, Jourdan E, Quittet P, Reme T, Lugagne C, Moine P, Rossi JF, Klein B, Tarte K. BAFF and APRIL protect myeloma cells from apoptosis induced by interleukin 6 deprivation and dexamethasone. Blood. 2004 Apr 15;103(8):3148-57. doi: 10.1182/blood-2003-06-1984. Epub 2003 Dec 4.

    PubMed 15070697

  • Tai YT, Acharya C, An G, Moschetta M, Zhong MY, Feng X, Cea M, Cagnetta A, Wen K, van Eenennaam H, van Elsas A, Qiu L, Richardson P, Munshi N, Anderson KC. APRIL and BCMA promote human multiple myeloma growth and immunosuppression in the bone marrow microenvironment. Blood. 2016 Jun 23;127(25):3225-36. doi: 10.1182/blood-2016-01-691162. Epub 2016 Apr 28.

    PubMed 27127303

  • Sanchez E, Li M, Kitto A, Li J, Wang CS, Kirk DT, Yellin O, Nichols CM, Dreyer MP, Ahles CP, Robinson A, Madden E, Waterman GN, Swift RA, Bonavida B, Boccia R, Vescio RA, Crowley J, Chen H, Berenson JR. Serum B-cell maturation antigen is elevated in multiple myeloma and correlates with disease status and survival. Br J Haematol. 2012 Sep;158(6):727-38. doi: 10.1111/j.1365-2141.2012.09241.x. Epub 2012 Jul 18.

    PubMed 22804669

  • Lee L, Bounds D, Paterson J, Herledan G, Sully K, Seestaller-Wehr LM, Fieles WE, Tunstead J, McCahon L, Germaschewski FM, Mayes PA, Craigen JL, Rodriguez-Justo M, Yong KL. Evaluation of B cell maturation antigen as a target for antibody drug conjugate mediated cytotoxicity in multiple myeloma. Br J Haematol. 2016 Sep;174(6):911-22. doi: 10.1111/bjh.14145. Epub 2016 Jun 17.

    PubMed 27313079

  • Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Anderson LD Jr, Sutherland HJ, Yong K, Hoos A, Gorczyca MM, Lahiri S, He Z, Austin DJ, Opalinska JB, Cohen AD. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial. Lancet Oncol. 2018 Dec;19(12):1641-1653. doi: 10.1016/S1470-2045(18)30576-X. Epub 2018 Nov 12.

    PubMed 30442502

  • 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.

    PubMed 31859245

Questions about this trial

What is this clinical trial studying?

An observational study of RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA, run by PETHEMA Foundation at 62 sites in Spain.

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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carmen López-Carrero (0034 699 835 437, carmen@fundacionpethema.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Throughout the study period. Approximately 3 years). 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 NCT05297240, which also lists 24 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 5 Aug 2022.

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