Clinical trial NCT05218603: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Non-eligible for Autologous Stem Cell Transplantation (ASCT)
Keywords: Prospective
Observational study
Multiple Myeloma
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
Collaborators: name: Janssen, LP
name: Adknoma Health Research
First posted: 2022-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients ≥18 years of age.
3. 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.

Exclusion Criteria:

1. 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.
2. 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Throughout the study period. Approximately 4 years
Secondary outcomes:
measure: Description of MRD status and depth
timeFrame: Throughout the study period. Approximately 4 years
measure: Stringent Complete Response (sCR) rate
timeFrame: Throughout the study period. Approximately 4 years
measure: Complete Response (CR) rate
timeFrame: Throughout the study period. Approximately 4 years
measure: Proportion of subjects who achieve Very Good Partial Response (VGPR) or better
timeFrame: Throughout the study period. Approximately 4 years
measure: Overall Response Rate (ORR)
timeFrame: Throughout the study period. Approximately 4 years
measure: Duration of response
timeFrame: Throughout the study period. Approximately 4 years
measure: Time to Progression (TTP)
timeFrame: Throughout the study period. Approximately 4 years
measure: Incidence of adverse events (AEs)
timeFrame: Throughout the study period. Approximately 4 years
Other outcomes:
Locations:
city: Arganda Del Rey
country: Spain
facility: Hospital Universitario Del Sureste
city: Barcelona
country: Spain
facility: Hospital Quirón Sagrado Corazón
city: Barcelona
country: Spain
facility: Hsopital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias (H.U.C)
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Ruber Juan Bravo 39
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Murcia
country: Spain
facility: Hospital General Universitario J.M. Morales Meseguer
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Plasencia
country: Spain
facility: Hospital Virgen Del Puerto
city: Ponferrada
country: Spain
facility: Hospital El Bierzo
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Quirónsalud Madrid
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Talavera De La Reina
country: Spain
facility: Hospital General Nuestra Señora Del Prado
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
city: Tomelloso
country: Spain
facility: Hospital General de Tomelloso
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Ávila
country: Spain
facility: Complejo Asistencial de Avila
Study officials:
affiliation: Hospital Universitario de Salamanca (Salamanca)
name: María Victoria Mateos Manteca
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universidad de Navarra (Pamplona)
name: Jesús San Miguel Izquierdo
role: PRINCIPAL_INVESTIGATOR
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