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Multiple MyelomaNCT05218603

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

An observational study of Multiple Myeloma and Non-eligible for Autologous Stem Cell Transplantation (ASCT), run by PETHEMA Foundation at 32 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomib and Daratumumab
How many people
100 participants
Where
32 sitesSpain
Study dates
30 Nov 2021to 6 Nov 2025
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: 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.

Who may be able to join

  • Patients with a newly diagnosed MM non eligible for ASCT that have received induction therapy with D-VMP (9 cycles) and followed by V-Dara as maintenance* in clinical practice. The decision to prescribe maintenance treatment with V-Dara must be in accordance with clinical practice, must not be influenced by the planned inclusion of a patient in the study, and should be documented before enrollment.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 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

32 sites in 1 country

Spain32 sites, 32 recruiting

  • Hospital Universitario Del Sureste

    Arganda

    Teresa Cobo Rodríguez

    Teresa Cobo Rodríguez

    Recruiting

  • Complejo Asistencial de Avila

    Ávila

    Abelardo Bárez García

    Abelardo Bárez García

    Recruiting

  • Hospital Quirón Sagrado Corazón

    Barcelona

    Miguel Sánchez Rey

    Miguel Sánchez Rey

    Recruiting

  • Hsopital Clinic de Barcelona

    Barcelona

    Laura Rosiñol

    Laura Rosiñol

    Recruiting

  • Hospital Universitario Virgen de Las Nieves

    Granada

    Esther Clavero Sánchez

    Esther Clavero Sánchez

    Not yet recruiting

  • Complejo Hospitalario de Jaén

    Jaén

    Magdalena Anguita

    Magdalena Anguita

    Recruiting

  • Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria

    Alexia Suarez Cabrera

    Alexia Suarez Cabrera

    Recruiting

  • Hospital de León

    León

    Fernando Escalante

    Fernando Escalante

    Recruiting

  • Hospital Clínico San Carlos

    Madrid

    Belén Íñigo

    Belén Íñigo

    Not yet recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid

    Cristina Encinas

    Cristina Encinas

    Recruiting

  • Hospital Ramón Y Cajal

    Madrid

    María Jesús Blanchard

    María Jesús Blanchard

    Recruiting

  • Hospital Ruber Juan Bravo 39

    Madrid

    Arancha Alonso

    Arancha Alonso

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid

    Adrián Alegre

    Adrián Alegre

    Not yet recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

    Elena Prieto Pareja

    Elena Prieto Pareja

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid

    José Ángel Hernández Rivas

    José Ángel Hernández Rivas

    Recruiting

  • Hospital General Universitario J.M. Morales Meseguer

    Murcia

    Felipe de Arriba de la Fuente

    Felipe de Arriba de la Fuente

    Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense

    José Ángel Méndez

    José Ángel Méndez

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo

    Ángel Ramírez Payer

    Ángel Ramírez Payer

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona

    Paula Rodríguez

    Paula Rodríguez

    Recruiting

  • Hospital Virgen Del Puerto

    Plasencia

    Rosa María López López

    Rosa María López López

    Recruiting

  • Hospital El Bierzo

    Ponferrada

    Carmen Aguilera

    Carmen Aguilera

    Recruiting

  • Hospital Montecelo

    Pontevedra

    Ana Dios Loureiro

    Ana Dios Loureiro

    Recruiting

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón

    Carmen Martínez Chamorro

    Carmen Martínez Chamorro

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca

    María Victoria Mateos Manteca

    María Victoria Mateos Manteca

    Recruiting

  • Hospital Universitario de Canarias (H.U.C)

    San Cristóbal de La Laguna

    Miguel Teodoro Hernandez Garcia

    Miguel Teodoro Hernandez Garcia

    Recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes

    Eugenio Giménez Mesa

    Eugenio Giménez Mesa

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander

    Enrique Ocio

    Enrique Ocio

    Recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela

    Marta Sonia González Pérez

    Marta Sonia González Pérez

    Recruiting

  • Hospital General Nuestra Señora Del Prado

    Talavera de la Reina

    Ana Lerma

    Ana Lerma

    Not yet recruiting

  • Hospital Universitari Mútua de Terrassa

    Terrassa

    Josep Martí

    Josep Martí

    Recruiting

  • Hospital General de Tomelloso

    Tomelloso

    Mónica López Rincón

    Mónica López Rincón

    Not yet recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid

    Alfonso García de Coca

    Alfonso García de Coca

    Recruiting

Other trials in Spain

About this study

Official title: A Prospective, Observational Study, to Evaluate the 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 Autologous Stem Cell Transplantation (ASCT): Alcyone-optimized Real World Evidence (RWE) Data

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.

Read the detailed description

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 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.

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.

Observational Phase:

Patients will be followed for 3-4 years since the inclusion in the study. Once the patient is enrolled in the study, retrospective data collection at the start and end of VMP-Dara induction will be collected. Subjects who discontinue maintenance therapy before disease progression (V or V-Dara), will continue to have response rate evaluations, PFS and toxicity recorded as per routine clinical practice, until the end of the study or progression, whatever comes first.

During this observational follow-up, both the duration of the initially prescribed V-Dara maintenance (and the time when bortezomib is stopped before daratumumab if this ever happens), the existence of potential adverse reactions and the fate of the disease in terms of progression and survival, even though the maintenance only daratumumab could have been stopped, will be documented for a total of up to 3-4 years. Maintenance with V-Dara, or just daratumumab once bortezomib is suspended, can be finalized due to progression, unacceptable toxicity or voluntary withdrawal.

This observational study has the following objectives:

Primary Objective:

  • To describe the effectiveness of V-Dara maintenance after VMPDara induction in patients with MM non-eligible for autologous stem cell transplantation in the Spanish clinical setting (clinical practice).

Secondary Objectives:

  • Compare the effectiveness of VMP-Dara induction followed by V-Dara maintenance with the results of the Daratumumab arm of the Alcyone trial (VMP-Dara followed by Dara maintenance).
  • To describe the safety of the V-Dara maintenance therapy used in clinical practice after VMP-Dara.
  • To evaluate the clinical effectiveness in different risk subgroups.
Being tested
Bortezomib, Daratumumab
Keywords
Prospective, Observational study, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • BortezomibDrug

    Maintenance: Administration as per routine clinical practice.

  • DaratumumabDrug

    Maintenance: Administration as per routine clinical practice.

Study groups in NCT05218603
Study groupRoleWhat they receive
Maintenance with V-Dara after receiving VMP-Dara as induction regimenMaintenance with bortezomib plus daratumumab (V-Dara) after induction with bortezomib, melphalan, prednisone plus daratumumab (VMP-Dara)
Receives: Drug: Bortezomib; Drug: Daratumumab

What is being measured

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

  1. Progression Free Survival (PFS)

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

    Measured: Throughout the study period. Approximately 4 years

Secondary outcomes (8)

  1. Description of MRD status and depth

    Description of MRD status and depth, that will be conducted on bone marrow samples and outside of the bone marrow through imaging techniques if available per routine clinical practice, according to the investigator's criteria.

    Measured: Throughout the study period. Approximately 4 years

  2. Stringent Complete Response (sCR) rate

    Measured: Throughout the study period. Approximately 4 years

  3. Complete Response (CR) rate

    Measured: Throughout the study period. Approximately 4 years

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

    Measured: Throughout the study period. Approximately 4 years

  5. Overall Response Rate (ORR)

    Measured: Throughout the study period. Approximately 4 years

  6. Duration of response

    Duration of response calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease.

    Measured: Throughout the study period. Approximately 4 years

  7. Time to Progression (TTP)

    Time to Progression (TTP), defined as the time from the date of start of VMP-Dara to the date of first documented evidence of PD.

    Measured: Throughout the study period. Approximately 4 years

  8. Incidence of adverse events (AEs)

    Number of patients experiencing AEs, classified according to severity.

    Measured: Throughout the study period. Approximately 4 years

Timeline

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

  1. First posted1 Feb 2022
  2. Study start30 Nov 2021
  3. Primary completion6 Nov 2025 (estimated)
  4. Study completion6 Nov 2025 (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
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218603
Sponsor's protocol ID
GEM-OPTIMAL
Status last verified
Sep 2022
First submitted
17 Jan 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
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

  • 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.

    PubMed 20610543

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

    PubMed 23386937

  • 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.

    PubMed 26031917

  • 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.

    PubMed 28151709

  • 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.

    PubMed 28726797

  • 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.

    PubMed 17344913

  • 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.

    PubMed 22271445

  • 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

  • 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.

  • 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.

    PubMed 22021371

  • 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.

    PubMed 16530576

  • 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.

    PubMed 20516439

  • 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.

    PubMed 20448107

  • 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.

    PubMed 20942865

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Non-eligible for Autologous Stem Cell Transplantation (ASCT), run by PETHEMA Foundation at 32 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 3 inclusion and 2 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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?

Progression Free Survival (PFS) (time frame: Throughout the study period. Approximately 4 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 NCT05218603, which also lists 36 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 16 Sep 2022.

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