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Efficacy of Response-adapted Treatment in Patients With Multiple Myeloma Candidates for Bone Marrow Transplantation

NCT05697913 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-03-06

No results posted yet for this study

Summary

To assess whether continued treatment to achieve negative Minimal Residual Disease and Imaging (MRDI(-)) improves therapeutic outcomes in patients with newly diagnosed Multiple Myeloma. The primary endpoints are progression-free survival (PFS) and overall survival (OS). The safety evaluation includes the evaluation of adverse events, which are classified according to the Common Criteria for Terminology for Adverse Events of the National Cancer Institute, version 5.0.

Conditions

Interventions

OTHER

Continued treatment adapted to the response

Instead of receiving a pre-specified number of treatment cycles, regardless of the result obtained, in the MRDI-driven treatment group patients continue receiving treatment until reaching a complete remission with negative MRD and Image, changing the therapeutic line if it is not obtained with the line current therapy. In this group of the patients the treatment was stopped only when this degree of deep response was achieved.

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Jose Enrique de la Puerta Rueda, MD · Hospital Cruz Roja de Bilbao

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2024-06-30
Completion
2024-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697913 on ClinicalTrials.gov