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Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not

ConditionsMultiple MyelomaMinimal Residual Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%.

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

Trial population

Primary multiple myeloma who achieved MRD negativity after induction therapy are screened by the eligibility Criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transplant, Autologous

    Drug

    High-dose melphalan followed by autologous stem cell transplantation

  • Chemotherapy drug

    Drug

    Regimen such as Bortezomib plus Lenalidomide plus Dexamethasone

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: ASCT regimen1 intervention
Group B: non ASCT regimen1 intervention

Trial outcomes

Primary outcomes

1

progression free survival

Progression-free survival is defined as the duration from diagnosis to the date of death, initial progression, or the last follow-up

Time frame
2-year

Secondary outcomes

1

sustain MRD negativity

The proportion of patients who are still MRD negative at 1-year, 2-years after achieving MRD negativity after induction therapy

Time frame
1-year, 2-year
2

Number of Participants With Treatment-Related Adverse Events

All adverse events and second primary malignancies

Time frame
Once enrolled, an average of 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborator

The Affiliated Hospital of Medical College, Ningbo University

Collaborator

Dongyang People's Hospital

Collaborator

Source ClinicalTrials.gov
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