MMAPPIN' Study: Multiple Myeloma Analysis For Patient-specific Insights to Dissect Disease Heterogeneity
This is a single-center, observational study in patients with multiple myeloma, conducted both retrospectively and prospectively. The study aims to improve understanding of the biological and clinical factors that influence disease progression, relapse, and treatment resistance.
The study will integrate clinical information with advanced genomic and molecular analyses, including whole genome and RNA sequencing, as well as circulating tumor markers, to identify features linked to therapy response and disease behavior. All data will be securely stored, maintaining patient confidentiality, to build a comprehensive map of multiple myeloma that may guide more personalized future treatments.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Carolina Terragna, MD
- 전화번호: 0512143831
- 이메일: carolina.terragna@unibo.it
연구 장소
-
-
Bo
-
Bologna, Bo, 이탈리아, 40138
- 모병
- IRCCS AOU Policlinico Sant'Orsola
-
연락하다:
- Carolina Terragna, MD
- 전화번호: 0512143680
- 이메일: carolina.terragna@unibo.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Study participants will be adult patients with monoclonal gammopathies, NDMM, RMM, and RRMM.
Basing on data of yearly access, the study aims to enroll approximately:
- 400 NDMM patients in a -36 months timeframe
- 20 patients with monoclonal gammopathies in a -36 months timeframe
- 50 RMM patients in a -36 months timeframe
- 50 RRMM patients in a -36 months timeframe In addition, a retrospective cohort of patients will be included in this study after obtaining signed informed consent. This cohort will comprise no more than 25% of the total enrolled participants regardless of the phase of their disease. Patients will be selected based on the availability of existing residual biological material (samples collected not before January 2020), which will be analyzed as part of this study.
설명
Inclusion Criteria:
- Age 18+
- Signed CI for study partecipation and personal data processing.
- Diagnosis of monoclonal gammopathy, or of acrive multiple myaloma (NDMM/RMM/RRMM)
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Response assessment (according to IMWG criteria) and / or disease progression (PD)
기간: 12 months after the start of therapy, in pre-neoplastic groups , only PD will be considered
|
12 months after the start of therapy, in pre-neoplastic groups , only PD will be considered
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Response to treatment <VGPR (according to IMWG criteria) and/or disease progression (PD)
기간: From baseline to disease progression (PD), assessed up to 24 months.
|
From baseline to disease progression (PD), assessed up to 24 months.
|
|
Presence and/or absence of "secondary" tumor clone(s)
기간: From baseline to disease progression (PD), assessed up to 24 months.
|
From baseline to disease progression (PD), assessed up to 24 months.
|
|
Presence and/or absence of differences between baseline characteristics and progression features
기간: From baseline to disease progression (PD), assessed up to 24 months.
|
From baseline to disease progression (PD), assessed up to 24 months.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .