NCT06463717Recruiting
Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not
Comparing the Efficacy and Safety of Autologous Hematopoietic Stem-cell Transplantation Versus Non Transplantation Regimen in Primary Multiple Myeloma Achieved MRD Negativity After Induction: A Multiple Center, Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 24 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction. The main question it aims to answer is: In primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice. Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 210 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 1 Dec 2023
- Primary completion date
- Nov 2028
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Multiple myeloma
- NCT number
- NCT06463717
What you commit to
- Study type: Observational
- Planned participants: 210
- From 1 Dec 2023 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia
- History of other malignant tumors within the past 5 years
- Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C
- Other serious condition that may restrict patients from continuing treatment (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency, or angina pectoris)
- General condition not suitable for chemotherapy
- Suffering from other serious organic diseases and mental disorders.
Other
- Two or more high-risk cytogenetic abnormalities, including del (17p), t (4; 14), t (14; 16), del (1p), amp (1q). Fluorescence in situ hybridization was used to analyze CD138 positive sorted cells, with cut off value of 15% for translocation, 10% for deletion, and amp (1q) of 20%.
- Pregnant or lactating women
Who the study is looking for
- Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma
- Age ranges from 18-70 years old
- Achieved MRD negativity and at least very good partial response in clinical response after 4-6 courses of induction therapy. MRD is measured by MRD by multicolor flow with a sensitivity of 10-5.
- At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2.
- Organ function requirement: Blood bilirubin ≤ 2mg/dL (35 μ mol/L), Alanine aminotransferase/Aspartate aminotransferase below 2 times the upper limit of normal value, Creatinine clearance rate (Ccr) ≥ 30ml/min and Cardiac ejection fraction ≥50%.
- Expected survival more than 3 months.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.