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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Carolina Terragna, MD
- 電話番号：0512143831
- メール：carolina.terragna@unibo.it
研究場所
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Bo
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Bologna、Bo、イタリア、40138
- 募集
- IRCCS AOU Policlinico Sant'Orsola
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コンタクト：
- Carolina Terragna, MD
- 電話番号：0512143680
- メール：carolina.terragna@unibo.it
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Response assessment (according to IMWG criteria) and / or disease progression (PD)
時間枠：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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Response to treatment <VGPR (according to IMWG criteria) and/or disease progression (PD)
時間枠：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)
時間枠：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
時間枠：From baseline to disease progression (PD), assessed up to 24 months.
|
From baseline to disease progression (PD), assessed up to 24 months.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。