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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05297240
Other study ID # GEM-RELAMAB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 24, 2022
Est. completion date December 2022

Study information

Verified date August 2022
Source PETHEMA Foundation
Contact Carmen López-Carrero
Phone 0034 699 835 437
Email carmen@fundacionpethema.es
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Belantamab mafodotin
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.

Locations

Country Name City State
Spain H. Universitario de Albacete Albacete
Spain H. Doctor José Molina Orosa Arrecife
Spain H. Ntra. Señora Sonsoles Ávila
Spain H. San Agustín Avilés
Spain H. Clinic de Barcelona Barcelona
Spain H. Moises Broggi Barcelona
Spain H. Vall d' Hebron Barcelona
Spain H. Basurto Bilbao
Spain H. Cruces Bilbao
Spain H. Calahorra Calahorra
Spain H. Reina Sofía Córdoba
Spain H. General Elche Elche
Spain H. Fuenlabrada Fuenlabrada
Spain H. Galdakao Galdakao
Spain H. Francisco de Borja Gandia
Spain ICO Girona Girona
Spain H. Un. Virgen de las Nieves Granada
Spain H. Un. Guadalajara Guadalajara
Spain H. Juan Ramón Jiménez Huelva
Spain H. Universitario de Jaén Jaén
Spain H. Un. Doctor Negrín Las Palmas De Gran Canaria
Spain H. Severo Ochoa Leganés
Spain H. León León
Spain H. San Pedro Logroño
Spain H. Un. Lucus Augusti Lugo
Spain Fundación Jiménez Díaz Madrid
Spain H. Gregorio Marañón Madrid
Spain H. Moncloa Madrid
Spain H. Ruber Juan Bravo Madrid
Spain H. Un. Doce de Octubre Madrid
Spain H. Un. Infanta Sofía Madrid
Spain H. Un. La Paz Madrid
Spain H. Un. La Princesa Madrid
Spain H. Un. Puerta del Hierro Madrid
Spain H. Un. Quirón Salud Madrid
Spain H.M. Sanchinarro Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario Henares Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain H. Virgen de la Victoria Málaga
Spain H. Rey Juan Carlos Móstoles
Spain H. Morales Meseguer Murcia
Spain H. Un. Virgen de la Arrixaca Murcia
Spain H. Universitario Central Asturias Oviedo
Spain H. Son Llatzer Palma De Mallorca
Spain H. Un. Son Espases Palma De Mallorca
Spain H. Montecelo Pontevedra
Spain H. Un. Salamanca Salamanca
Spain H. Un. Canarias Santa Cruz De Tenerife
Spain H. Un. Marqués de Valdecilla Santander
Spain H. General Segovia Segovia
Spain H. Un. Virgen de Valme Sevilla
Spain H. Virgen del Rocío Sevilla
Spain H. Mutua Terrasa Terrassa
Spain H. Ntra. Señora del Prado Toledo
Spain H. Un. Torrejón Torrejón De Ardoz
Spain H. Un. Dr. Peset Valencia
Spain H. Universitario de la Fe Valencia
Spain H. Universitario de Valladolid Valladolid
Spain H. Clinico Un. Lozano Blesa Zaragoza
Spain H. Miguel Servet Zaragoza
Spain H. Royo Villanova Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
PETHEMA Foundation GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Bergin K, McQuilten Z, Moore E, Wood E, Spencer A. Myeloma in the Real World: What Is Really Happening? Clin Lymphoma Myeloma Leuk. 2017 Mar;17(3):133-144.e1. doi: 10.1016/j.clml.2016.12.002. Epub 2016 Dec 26. Review. — View Citation

Chari A, Romanus D, Palumbo A, Blazer M, Farrelly E, Raju A, Huang H, Richardson P. Randomized Clinical Trial Representativeness and Outcomes in Real-World Patients: Comparison of 6 Hallmark Randomized Clinical Trials of Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2020 Jan;20(1):8-17.e16. doi: 10.1016/j.clml.2019.09.625. Epub 2019 Oct 10. — View Citation

Fiala M, et al. The real-world characteristics and outcomes of newly diagnosed myeloma patients ineligible for clinical trials. Clin. Lymphoma Myeloma Leuk. 2017;17:e55-e56

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. — View Citation

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. Review. — View Citation

Hungria VTM, et al. Real-world (RW) multiple myeloma (MM) patients (Pts) remain under-represented in clinical trials based on standard laboratory parameters and baseline characteristics: analysis of over 3,000 Pts from the Insight MM Global, Prospective, Observational Study. Blood. 2019;134:1887a

Klausen TW, Gregersen H, Abildgaard N, Andersen NF, Frølund UC, Gimsing P, Helleberg C, Vangsted AJ. The majority of newly diagnosed myeloma patients do not fulfill the inclusion criteria in clinical phase III trials. Leukemia. 2019 Feb;33(2):546-549. doi: 10.1038/s41375-018-0272-0. Epub 2018 Sep 28. — View Citation

Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Bladé J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lonial S, Lee HC, Badros A, et al. Cancer. 2021 Jul 27. doi: 10.1002/cncr.33809. Online ahead of print. PMID: 34314018

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, Kortüm KM, Rodríguez-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. — View Citation

Moreaux J, Legouffe E, Jourdan E, Quittet P, Rème 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. Epub 2003 Dec 4. — View Citation

Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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, Lüoend 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, Umaña 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. — View Citation

Shah JJ, Abonour R, Gasparetto C, Hardin JW, Toomey K, Narang M, Srinivasan S, Kitali A, Zafar F, Flick ED, Rifkin RM. Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes. Clin Lymphoma Myeloma Leuk. 2017 Sep;17(9):575-583.e2. doi: 10.1016/j.clml.2017.06.013. Epub 2017 Jun 17. — View Citation

Song X, Cong Z, Wilson K. Real-world treatment patterns, comorbidities, and disease-related complications in patients with multiple myeloma in the United States. Curr Med Res Opin. 2016;32(1):95-103. doi: 10.1185/03007995.2015.1105202. Epub 2015 Nov 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Incidence of treatment-emergent adverse events (AEs) Number and percentage of treatment-emergent adverse events (AEs) Throughout the study period. Approximately 3 years
Secondary Incidence of ocular events Number and percentage of ocular events Throughout the study period. Approximately 3 years
Secondary 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
Secondary 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
Secondary 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
Secondary Progression free survival (PFS) The time from start of treatment until progression or death from any cause Throughout the study period. Approximately 3 years
Secondary Overall survival (OS) The time from start of treatment until death from any cause. Throughout the study period. Approximately 3 years
Secondary 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
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