Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT

NCT05218603 | Unknown

• 1 other identifier: GEM-OPTIMAL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 32

Brief Summary

This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT. Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice (screening and enrollment visit) and followed during 3-4 years in what will be called the Observational Phase. During this phase, the patient will be followed by his/her doctor as per routine clinical practice, according to his/her disease. The patient will not suffer any changes in his/her treatment or follow-up due to his/her participation in the study. The patient will receive standard clinical practice and he/she will not do any other study-specific visit. During this 3-4-year observational phase, the patient might discontinue V or V-Dara,depending on toxicity, efficacy or due to other medical reasons, according to his/her physician decision.

Conditions

Multiple Myeloma; Non-eligible for Autologous Stem Cell Transplantation (ASCT)

Keywords

Prospective; Observational study; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Time from the start of induction with VMPDara until disease progression or death, whichever comes first

  Throughout the study period. Approximately 4 years

Secondary Outcomes (8)

• Description of MRD status and depth

  Throughout the study period. Approximately 4 years

• Stringent Complete Response (sCR) rate

  Throughout the study period. Approximately 4 years

• Complete Response (CR) rate

  Throughout the study period. Approximately 4 years

• Proportion of subjects who achieve Very Good Partial Response (VGPR) or better

  Throughout the study period. Approximately 4 years

• Overall Response Rate (ORR)

  Throughout the study period. Approximately 4 years

Study Arms (1)

Maintenance with V-Dara after receiving VMP-Dara as induction regimen

Maintenance with bortezomib plus daratumumab (V-Dara) after induction with bortezomib, melphalan, prednisone plus daratumumab (VMP-Dara)

Drug: Bortezomib; Drug: Daratumumab

Interventions

Bortezomib DRUG

Maintenance: Administration as per routine clinical practice.

Maintenance with V-Dara after receiving VMP-Dara as induction regimen

Daratumumab DRUG

Maintenance: Administration as per routine clinical practice.

Maintenance with V-Dara after receiving VMP-Dara as induction regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A target of approximately 100 subjects from the centers opened in the study will be recruited only if patients have received induction therapy with VMP-Dara followed by V-Dara as maintenance therapy for at least one cycle prior to the start of the study (treatment has to be previously decided as part of clinical practice). This way, patients must have already been treated with 9 cycles of VMP-Dara (approximately 12 months) and at least 1 cycle of V-Dara maintenance (1 month), before entering the study. This implies that the decision to prescribe this maintenance schedule is clearly unrelated to the decision of enrolling the patient into the study.

You may qualify if:

• Patients ≥18 years of age.
• Each subject (or their legally acceptable representative) must sign the ICF indicating that he or she understands the purpose of the observational nature the study and are willing to share his/her clinical data for the study.

You may not qualify if:

• Patients with a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering MM, plasma cell leukemia, POEMS syndrome, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
• Subjects with prior or current systemic therapy or ASCT for MM (before VMP-Dara induction), except for an emergency use of a short course of corticosteroids before treatment.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Janssen, LP: collaborator
• Adknoma Health Research: collaborator

Study Sites (32)

Hospital Universitario Del Sureste

Arganda, Spain

RECRUITING

Complejo Asistencial de Avila

Ávila, Spain

RECRUITING

Hospital Quirón Sagrado Corazón

Barcelona, Spain

RECRUITING

Hsopital Clinic de Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario Virgen de Las Nieves

Granada, Spain

NOT YET RECRUITING

Complejo Hospitalario de Jaén

Jaén, Spain

RECRUITING

Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital de León

León, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Ramón Y Cajal

Madrid, Spain

RECRUITING

Hospital Ruber Juan Bravo 39

Madrid, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Hospital General Universitario J.M. Morales Meseguer

Murcia, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Hospital Virgen Del Puerto

Plasencia, Spain

RECRUITING

Hospital El Bierzo

Ponferrada, Spain

RECRUITING

Hospital Montecelo

Pontevedra, Spain

RECRUITING

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitario de Canarias (H.U.C)

San Cristóbal de La Laguna, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital General Nuestra Señora Del Prado

Talavera de la Reina, Spain

NOT YET RECRUITING

Hospital Universitari Mútua de Terrassa

Terrassa, Spain

RECRUITING

Hospital General de Tomelloso

Tomelloso, Spain

NOT YET RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

RECRUITING

Related Publications (36)

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

  PMID: 21410373 BACKGROUND

• Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

  PMID: 20610543 BACKGROUND

• Al-Farsi K. Multiple myeloma: an update. Oman Med J. 2013 Jan;28(1):3-11. doi: 10.5001/omj.2013.02.

  PMID: 23386937 BACKGROUND

• Bianchi G, Richardson PG, Anderson KC. Promising therapies in multiple myeloma. Blood. 2015 Jul 16;126(3):300-10. doi: 10.1182/blood-2015-03-575365. Epub 2015 Jun 1. No abstract available.

  PMID: 26031917 BACKGROUND

• Anderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625.

  PMID: 28151709 BACKGROUND

• Kumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, Gay F, Anderson KC. Multiple myeloma. Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038/nrdp.2017.46.

  PMID: 28726797 BACKGROUND

• Mihelic R, Kaufman JL, Lonial S. Maintenance therapy in multiple myeloma. Leukemia. 2007 Jun;21(6):1150-7. doi: 10.1038/sj.leu.2404633. Epub 2007 Mar 8.

  PMID: 17344913 BACKGROUND

• Ludwig H, Durie BG, McCarthy P, Palumbo A, San Miguel J, Barlogie B, Morgan G, Sonneveld P, Spencer A, Andersen KC, Facon T, Stewart KA, Einsele H, Mateos MV, Wijermans P, Waage A, Beksac M, Richardson PG, Hulin C, Niesvizky R, Lokhorst H, Landgren O, Bergsagel PL, Orlowski R, Hinke A, Cavo M, Attal M; International Myeloma Working Group. IMWG consensus on maintenance therapy in multiple myeloma. Blood. 2012 Mar 29;119(13):3003-15. doi: 10.1182/blood-2011-11-374249. Epub 2012 Jan 23.

  PMID: 22271445 BACKGROUND

• Nooka, A.K., Behera, M., Boise, L.H., Kaufman, J.L., Watson, M. and Lonial, S. (2011) Thalidomide as maintenance therapy in multiple myeloma (MM) improves progression free survival (PFS) and overall survival (OS): a meta-analysis. ASH Annu. Meet. Abstr. 118, 1855

  BACKGROUND

• Hahn, A., Lilienfeld, T.M. and Heteren, P. (2011) Improved progression-free and overall survival with thalidomide maintenance therapy after autologous stem cell transplantation in multiple myeloma: a meta-analysis of five randomized trials. Haematologica 96, 884.

  BACKGROUND

• Morgan GJ, Gregory WM, Davies FE, Bell SE, Szubert AJ, Brown JM, Coy NN, Cook G, Russell NH, Rudin C, Roddie H, Drayson MT, Owen RG, Ross FM, Jackson GH, Child JA; National Cancer Research Institute Haematological Oncology Clinical Studies Group. The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysis. Blood. 2012 Jan 5;119(1):7-15. doi: 10.1182/blood-2011-06-357038. Epub 2011 Oct 20.

  PMID: 22021371 BACKGROUND

• Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.

  PMID: 16530576 BACKGROUND

• Wijermans P, Schaafsma M, Termorshuizen F, Ammerlaan R, Wittebol S, Sinnige H, Zweegman S, van Marwijk Kooy M, van der Griend R, Lokhorst H, Sonneveld P; Dutch-Belgium Cooperative Group HOVON. Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study. J Clin Oncol. 2010 Jul 1;28(19):3160-6. doi: 10.1200/JCO.2009.26.1610. Epub 2010 Jun 1.

  PMID: 20516439 BACKGROUND

• Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Bjorkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukas E, Hjertner O, Hjorth M, Karlsson T, Knudsen LM, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sorbo JH, Wisloff F, Juliusson G, Turesson I; Nordic Myeloma Study Group. Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. 2010 Sep 2;116(9):1405-12. doi: 10.1182/blood-2009-08-237974. Epub 2010 May 6.

  PMID: 20448107 BACKGROUND

• Beksac M, Haznedar R, Firatli-Tuglular T, Ozdogu H, Aydogdu I, Konuk N, Sucak G, Kaygusuz I, Karakus S, Kaya E, Ali R, Gulbas Z, Ozet G, Goker H, Undar L. Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Group. Eur J Haematol. 2011 Jan;86(1):16-22. doi: 10.1111/j.1600-0609.2010.01524.x. Epub 2010 Nov 22.

  PMID: 20942865 BACKGROUND

• Yang B, Yu RL, Chi XH, Lu XC. Lenalidomide treatment for multiple myeloma: systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 May 14;8(5):e64354. doi: 10.1371/journal.pone.0064354. Print 2013.

  PMID: 23691202 BACKGROUND

• Palumbo A, Bringhen S, Kumar SK, Lupparelli G, Usmani S, Waage A, Larocca A, van der Holt B, Musto P, Offidani M, Petrucci MT, Evangelista A, Zweegman S, Nooka AK, Spencer A, Dimopoulos MA, Hajek R, Cavo M, Richardson P, Lonial S, Ciccone G, Boccadoro M, Anderson K, Barlogie B, Sonneveld P, McCarthy PL. Second primary malignancies with lenalidomide therapy for newly diagnosed myeloma: a meta-analysis of individual patient data. Lancet Oncol. 2014 Mar;15(3):333-42. doi: 10.1016/S1470-2045(13)70609-0. Epub 2014 Feb 11.

  PMID: 24525202 BACKGROUND

• Adams J. The proteasome: a suitable antineoplastic target. Nat Rev Cancer. 2004 May;4(5):349-60. doi: 10.1038/nrc1361. No abstract available.

  PMID: 15122206 BACKGROUND

• Yang H, Zonder JA, Dou QP. Clinical development of novel proteasome inhibitors for cancer treatment. Expert Opin Investig Drugs. 2009 Jul;18(7):957-71. doi: 10.1517/13543780903002074.

  PMID: 19505187 BACKGROUND

• Avet-Loiseau H, Leleu X, Roussel M, Moreau P, Guerin-Charbonnel C, Caillot D, Marit G, Benboubker L, Voillat L, Mathiot C, Kolb B, Macro M, Campion L, Wetterwald M, Stoppa AM, Hulin C, Facon T, Attal M, Minvielle S, Harousseau JL. Bortezomib plus dexamethasone induction improves outcome of patients with t(4;14) myeloma but not outcome of patients with del(17p). J Clin Oncol. 2010 Oct 20;28(30):4630-4. doi: 10.1200/JCO.2010.28.3945. Epub 2010 Jul 19.

  PMID: 20644101 BACKGROUND

• McCarthy PL, Einsele H, Attal M, Giralt S. The emerging role of consolidation and maintenance therapy for transplant-eligible multiple myeloma patients. Expert Rev Hematol. 2014 Feb;7(1):55-66. doi: 10.1586/17474086.2014.878645. Epub 2014 Jan 29.

  PMID: 24471885 BACKGROUND

• Rollig C, Knop S, Bornhauser M. Multiple myeloma. Lancet. 2015 May 30;385(9983):2197-208. doi: 10.1016/S0140-6736(14)60493-1. Epub 2014 Dec 23.

  PMID: 25540889 BACKGROUND

• Sun CY, Li JY, Chu ZB, Zhang L, Chen L, Hu Y. Efficacy and safety of bortezomib maintenance in patients with newly diagnosed multiple myeloma: a meta-analysis. Biosci Rep. 2017 Jul 27;37(4):BSR20170304. doi: 10.1042/BSR20170304. Print 2017 Aug 31.

  PMID: 28706008 BACKGROUND

• Mateos MV, Oriol A, Martinez-Lopez J, Gutierrez N, Teruel AI, de Paz R, Garcia-Larana J, Bengoechea E, Martin A, Mediavilla JD, Palomera L, de Arriba F, Gonzalez Y, Hernandez JM, Sureda A, Bello JL, Bargay J, Penalver FJ, Ribera JM, Martin-Mateos ML, Garcia-Sanz R, Cibeira MT, Ramos ML, Vidriales MB, Paiva B, Montalban MA, Lahuerta JJ, Blade J, Miguel JF. Bortezomib, melphalan, and prednisone versus bortezomib, thalidomide, and prednisone as induction therapy followed by maintenance treatment with bortezomib and thalidomide versus bortezomib and prednisone in elderly patients with untreated multiple myeloma: a randomised trial. Lancet Oncol. 2010 Oct;11(10):934-41. doi: 10.1016/S1470-2045(10)70187-X. Epub 2010 Aug 23.

  PMID: 20739218 BACKGROUND

• Mateos MV, Oriol A, Martinez-Lopez J, Gutierrez N, Teruel AI, Lopez de la Guia A, Lopez J, Bengoechea E, Perez M, Polo M, Palomera L, de Arriba F, Gonzalez Y, Hernandez JM, Granell M, Bello JL, Bargay J, Penalver FJ, Ribera JM, Martin-Mateos ML, Garcia-Sanz R, Lahuerta JJ, Blade J, San-Miguel JF. Maintenance therapy with bortezomib plus thalidomide or bortezomib plus prednisone in elderly multiple myeloma patients included in the GEM2005MAS65 trial. Blood. 2012 Sep 27;120(13):2581-8. doi: 10.1182/blood-2012-05-427815. Epub 2012 Aug 13.

  PMID: 22889759 BACKGROUND

• Palumbo A, Bringhen S, Rossi D, Cavalli M, Larocca A, Ria R, Offidani M, Patriarca F, Nozzoli C, Guglielmelli T, Benevolo G, Callea V, Baldini L, Morabito F, Grasso M, Leonardi G, Rizzo M, Falcone AP, Gottardi D, Montefusco V, Musto P, Petrucci MT, Ciccone G, Boccadoro M. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: a randomized controlled trial. J Clin Oncol. 2010 Dec 1;28(34):5101-9. doi: 10.1200/JCO.2010.29.8216. Epub 2010 Oct 12.

  PMID: 20940200 BACKGROUND

• Palumbo A, Bringhen S, Larocca A, Rossi D, Di Raimondo F, Magarotto V, Patriarca F, Levi A, Benevolo G, Vincelli ID, Grasso M, Franceschini L, Gottardi D, Zambello R, Montefusco V, Falcone AP, Omede P, Marasca R, Morabito F, Mina R, Guglielmelli T, Nozzoli C, Passera R, Gaidano G, Offidani M, Ria R, Petrucci MT, Musto P, Boccadoro M, Cavo M. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. J Clin Oncol. 2014 Mar 1;32(7):634-40. doi: 10.1200/JCO.2013.52.0023. Epub 2014 Jan 21.

  PMID: 24449241 BACKGROUND

• Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Kaplan P, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Chiu C, Wang J, Carson R, Crist W, Deraedt W, Nguyen H, Qi M, San-Miguel J; ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12.

  PMID: 29231133 BACKGROUND

• Mateos MV, Richardson PG, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, Spicka I, Petrucci MT, Palumbo A, Samoilova OS, Dmoszynska A, Abdulkadyrov KM, Schots R, Jiang B, Esseltine DL, Liu K, Cakana A, van de Velde H, San Miguel JF. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010 May 1;28(13):2259-66. doi: 10.1200/JCO.2009.26.0638. Epub 2010 Apr 5.

  PMID: 20368561 BACKGROUND

• Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.

  PMID: 25439696 BACKGROUND

• Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.

  PMID: 16855634 BACKGROUND

• Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.

  PMID: 21292775 BACKGROUND

• Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade 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.

  PMID: 27511158 BACKGROUND

• Ladetto M, Bruggemann M, Monitillo L, Ferrero S, Pepin F, Drandi D, Barbero D, Palumbo A, Passera R, Boccadoro M, Ritgen M, Gokbuget N, Zheng J, Carlton V, Trautmann H, Faham M, Pott C. Next-generation sequencing and real-time quantitative PCR for minimal residual disease detection in B-cell disorders. Leukemia. 2014 Jun;28(6):1299-307. doi: 10.1038/leu.2013.375. Epub 2013 Dec 17.

  PMID: 24342950 BACKGROUND

• Martinez-Lopez J, Lahuerta JJ, Pepin F, Gonzalez M, Barrio S, Ayala R, Puig N, Montalban MA, Paiva B, Weng L, Jimenez C, Sopena M, Moorhead M, Cedena T, Rapado I, Mateos MV, Rosinol L, Oriol A, Blanchard MJ, Martinez R, Blade J, San Miguel J, Faham M, Garcia-Sanz R. Prognostic value of deep sequencing method for minimal residual disease detection in multiple myeloma. Blood. 2014 May 15;123(20):3073-9. doi: 10.1182/blood-2014-01-550020. Epub 2014 Mar 19.

  PMID: 24646471 BACKGROUND

• Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication. J Pharmacol Pharmacother. 2010 Jan;1(1):42-58. No abstract available.

  PMID: 21808590 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• María Victoria Mateos Manteca

  Hospital Universitario de Salamanca (Salamanca)

  PRINCIPAL INVESTIGATOR

• Jesús San Miguel Izquierdo

  Clínica Universidad de Navarra (Pamplona)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen López-Carrero

CONTACT

0034 699 835 437; carmen@fundacionpethema.es

Roberto Maldonado

CONTACT

0034 683 15 66 87; roberto.maldonado@fundacionpethema.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 1, 2022
• Study Start: November 30, 2021
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (32)