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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

Sponsor
PETHEMA Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05218603
Collaborator
Janssen, LP (Industry), Adknoma Health Research (Industry)
100
Enrollment
33
Locations
47.2
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Nov 6, 2025
Anticipated Study Completion Date :
Nov 6, 2025

Arms and Interventions

Arm Intervention/Treatment
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
Maintenance: Administration as per routine clinical practice.

Drug: Daratumumab
Maintenance: Administration as per routine clinical practice.

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival (PFS) [Throughout the study period. Approximately 4 years]

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

Secondary Outcome Measures

  1. Description of MRD status and depth [Throughout the study period. Approximately 4 years]

    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.

  2. Stringent Complete Response (sCR) rate [Throughout the study period. Approximately 4 years]

  3. Complete Response (CR) rate [Throughout the study period. Approximately 4 years]

  4. Proportion of subjects who achieve Very Good Partial Response (VGPR) or better [Throughout the study period. Approximately 4 years]

  5. Overall Response Rate (ORR) [Throughout the study period. Approximately 4 years]

  6. Duration of response [Throughout the study period. Approximately 4 years]

    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.

  7. Time to Progression (TTP) [Throughout the study period. Approximately 4 years]

    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.

  8. Incidence of adverse events (AEs) [Throughout the study period. Approximately 4 years]

    Number of patients experiencing AEs, classified according to severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Del Sureste Arganda Del Rey Spain
2 Hospital Del Mar Barcelona Spain
3 Hospital Quirón Sagrado Corazón Barcelona Spain
4 Hsopital Clinic de Barcelona Barcelona Spain
5 Hospital Universitario Virgen de Las Nieves Granada Spain
6 Complejo Hospitalario de Jaén Jaén Spain
7 Hospital Universitario de Canarias (H.U.C) La Laguna Spain
8 Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín Las Palmas De Gran Canaria Spain
9 Hospital de León León Spain
10 Hospital Clínico San Carlos Madrid Spain
11 Hospital General Universitario Gregorio Marañón Madrid Spain
12 Hospital Ramón Y Cajal Madrid Spain
13 Hospital Ruber Juan Bravo 39 Madrid Spain
14 Hospital Universitario de La Princesa Madrid Spain
15 Hospital Universitario Fundación Jiménez Díaz Madrid Spain
16 Hospital Universitario Infanta Leonor Madrid Spain
17 Hospital General Universitario J.M. Morales Meseguer Murcia Spain
18 Complexo Hospitalario Universitario de Ourense Ourense Spain
19 Hospital Universitario Central de Asturias Oviedo Spain
20 Clinica Universidad de Navarra Pamplona Spain
21 Hospital Virgen Del Puerto Plasencia Spain
22 Hospital El Bierzo Ponferrada Spain
23 Hospital Montecelo Pontevedra Spain
24 Hospital Quirónsalud Madrid Pozuelo De Alarcón Spain
25 Hospital Universitario de Salamanca Salamanca Spain
26 Hospital Universitario Infanta Sofía San Sebastián De Los Reyes Spain
27 Hospital Universitario Marqués de Valdecilla Santander Spain
28 Hospital Clinico Universitario de Santiago Santiago De Compostela Spain
29 Hospital General Nuestra Señora Del Prado Talavera De La Reina Spain
30 Hospital Universitari Mútua de Terrassa Terrassa Spain
31 Hospital General de Tomelloso Tomelloso Spain
32 Hospital Clinico Universitario de Valladolid Valladolid Spain
33 Complejo Asistencial de Avila Ávila Spain

Sponsors and Collaborators

  • PETHEMA Foundation
  • Janssen, LP
  • Adknoma Health Research

Investigators

  • Principal Investigator: María Victoria Mateos Manteca, Hospital Universitario de Salamanca (Salamanca)
  • Principal Investigator: Jesús San Miguel Izquierdo, Clínica Universidad de Navarra (Pamplona)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT05218603
Other Study ID Numbers:
  • GEM-OPTIMAL
First Posted:
Feb 1, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by PETHEMA Foundation
Prospective
Observational study
Multiple Myeloma
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Bortezomib
Daratumumab

Study Results

No Results Posted as of Mar 11, 2022