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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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).
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the study period. Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (AEs) | Number and percentage of treatment-emergent adverse events (AEs) | Throughout the study period. Approximately 3 years |
| Incidence of ocular events |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen López-Carrero | Contact | 0034 699 835 437 | carmen@fundacionpethema.es | |
| Roberto Maldonado | Contact | 0034 683 15 66 87 | roberto.maldonado@fundacionpethema.es |
| Name | Affiliation | Role |
|---|---|---|
| Javier de la Rubia | HOSPITAL LA FE VALENCIA | Principal Investigator |
| Adrián Alegre | Hospital La Princesa (Madrid) | Principal Investigator |
| María Victoria Mateos |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Universitario de Albacete | Recruiting | Albacete | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21410373 | Background | Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available. | |
| 24157580 | Background | 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. |
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Number and percentage of ocular events
| Throughout the study period. Approximately 3 years |
| Duration of response (DOR) | The time from first date of PR or better to date of disease progression or death due to any cause. | Throughout the study period. Approximately 3 years |
| Time to response (TTR) | The time from date of first dose of belantamab mafodotin to date of first occurrence of response. | Throughout the study period. Approximately 3 years |
| Time to next treatment (TTNT). | The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment. | Throughout the study period. Approximately 3 years |
| Progression free survival (PFS) | The time from start of treatment until progression or death from any cause | Throughout the study period. Approximately 3 years |
| Overall survival (OS) | The time from start of treatment until death from any cause. | Throughout the study period. Approximately 3 years |
| 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. | Throughout the study period. Approximately 3 years |
| Hospital Clínico, Salamanca |
| Principal Investigator |
| H. Doctor José Molina Orosa | Recruiting | Arrecife | Spain |
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| H. San Agustín | Recruiting | Avilés | Spain |
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| H. Ntra. Señora Sonsoles | Recruiting | Ávila | Spain |
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| H. Clinic de Barcelona | Recruiting | Barcelona | Spain |
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| H. Moises Broggi | Recruiting | Barcelona | Spain |
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| H. Vall d' Hebron | Recruiting | Barcelona | Spain |
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| H. Basurto | Recruiting | Bilbao | Spain |
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| H. Cruces | Recruiting | Bilbao | Spain |
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| H. Calahorra | Recruiting | Calahorra | Spain |
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| H. Reina Sofía | Recruiting | Córdoba | Spain |
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| H. General Elche | Recruiting | Elche | Spain |
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| H. Fuenlabrada | Recruiting | Fuenlabrada | Spain |
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| H. Galdakao | Recruiting | Galdakao | Spain |
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| H. Francisco de Borja | Recruiting | Gandia | Spain |
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| ICO Girona | Recruiting | Girona | Spain |
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| H. Un. Virgen de las Nieves | Recruiting | Granada | Spain |
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| H. Un. Guadalajara | Recruiting | Guadalajara | Spain |
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| H. Juan Ramón Jiménez | Recruiting | Huelva | Spain |
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| H. Universitario de Jaén | Recruiting | Jaén | Spain |
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| H. Un. Doctor Negrín | Recruiting | Las Palmas de Gran Canaria | Spain |
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| H. Severo Ochoa | Recruiting | Leganés | Spain |
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| H. León | Recruiting | León | Spain |
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| H. San Pedro | Recruiting | Logroño | Spain |
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| H. Un. Lucus Augusti | Recruiting | Lugo | Spain |
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| Fundación Jiménez Díaz | Recruiting | Madrid | Spain |
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| H. Gregorio Marañón | Recruiting | Madrid | Spain |
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| H. Moncloa | Recruiting | Madrid | Spain |
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| H. Ruber Juan Bravo | Recruiting | Madrid | Spain |
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| H. Un. Doce de Octubre | Recruiting | Madrid | Spain |
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| H. Un. Infanta Sofía | Recruiting | Madrid | Spain |
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| H. Un. La Paz | Recruiting | Madrid | Spain |
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| H. Un. La Princesa | Recruiting | Madrid | Spain |
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| H. Un. Puerta del Hierro | Recruiting | Madrid | Spain |
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| H. Un. Quirón Salud | Recruiting | Madrid | Spain |
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| H.M. Sanchinarro | Recruiting | Madrid | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | Spain |
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| Hospital Universitario Henares | Recruiting | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
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| H. Virgen de la Victoria | Recruiting | Málaga | Spain |
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| H. Rey Juan Carlos | Recruiting | Móstoles | Spain |
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| H. Morales Meseguer | Recruiting | Murcia | Spain |
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| H. Un. Virgen de la Arrixaca | Recruiting | Murcia | Spain |
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| H. Universitario Central Asturias | Recruiting | Oviedo | Spain |
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| H. Son Llatzer | Recruiting | Palma de Mallorca | Spain |
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| H. Un. Son Espases | Recruiting | Palma de Mallorca | Spain |
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| H. Montecelo | Recruiting | Pontevedra | Spain |
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| H. Un. Salamanca | Recruiting | Salamanca | Spain |
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| H. Un. Canarias | Recruiting | Santa Cruz de Tenerife | Spain |
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| H. Un. Marqués de Valdecilla | Recruiting | Santander | Spain |
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| H. General Segovia | Recruiting | Segovia | Spain |
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| H. Un. Virgen de Valme | Recruiting | Seville | Spain |
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| H. Virgen del Rocío | Recruiting | Seville | Spain |
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| H. Mutua Terrasa | Recruiting | Terrassa | Spain |
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| H. Ntra. Señora del Prado | Recruiting | Toledo | Spain |
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| H. Un. Torrejón | Recruiting | Torrejón de Ardoz | Spain |
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| H. Un. Dr. Peset | Recruiting | Valencia | Spain |
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| H. Universitario de la Fe | Recruiting | Valencia | Spain |
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| H. Universitario de Valladolid | Recruiting | Valladolid | Spain |
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| H. Clinico Un. Lozano Blesa | Recruiting | Zaragoza | Spain |
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| H. Miguel Servet | Recruiting | Zaragoza | Spain |
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| H. Royo Villanova | Recruiting | Zaragoza | Spain |
|
| 30820879 | Background | 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. |
| 31590151 | Background | 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. |
| 27506540 | Background | 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. |
| 22017435 | Background | 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. |
| 24385542 | Background | 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. |
| 24569262 | Background | 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. |
| 28262554 | Background | 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. |
| 15070697 | Background | 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. |
| 27127303 | Background | 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. |
| 22804669 | Background | 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. |
| 27313079 | Background | 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. |
| 30442502 | Background | 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. |
| 31859245 | Background | 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. |
| Background | Lonial S, Lee HC, Badros A, et al. Cancer. 2021 Jul 27. doi: 10.1002/cncr.33809. Online ahead of print. PMID: 34314018 |
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| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
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