Clinical Research of Pomalidomide Maintenance Therapy for Primary Multiple Myeloma

October 3, 2023 updated by: Hao Zhang, LanZhou University
The trial is a single-center, single-arm, prospective clinical study with a planned enrollment of 15 patients with primary Multiple myeloma(MM), aiming to investigate the efficacy and safety of maintenance therapy with Pomalidomide in patients with primary MM. Patients enrolled were divided into two categories: 1) patients suitable for Autologous Hematopoietic Stem Cell Transplantation(ASCT) started pomalidomide maintenance therapy 3 months after ASCT; 2) patients not suitable for ASCT started pomalidomide maintenance therapy after induction and consolidation therapy to achieve maximum efficacy. Dosing on days 1-21, 2 mg daily for 28 days as a cycle, for a total duration of 36 months or the onset of disease progression, intolerable adverse events. 2-year progression-free survival (2y-PFS) was used as the primary study endpoint, 2-year overall survival (2y-OS), complete remission rate (CR), very good partial remission rate (VGPR), and negative rate of minimal residual disease(MRD) were secondary study endpoints, and the incidence of adverse events (AEs) was assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Maintenance regimens based on thalidomide and lenalidomide have been shown in numerous clinical trials to significantly improve PFS in patients, but the use of thalidomide is limited by adverse effects such as peripheral neurotoxicity and post-relapse drug resistance. Pomalidomide is a third-generation immunomodulator with a similar structure to thalidomide and lenalidomide, but with stronger anti-MM activity and a similar safety profile. The known mechanisms of action include (1) immunomodulatory effects (2) direct antitumor effects (3) anti-angiogenic activity. (4) Effects on the bone marrow microenvironment. The most common toxicities of pomalidomide include bone marrow suppression, skin reactions, gastrointestinal reactions, and infections, etc. Peripheral neuropathy is less common than thalidomide, and the incidence of thromboembolism is <5%. Pomalidomide is currently used mainly in the treatment of relapsed refractory adult MM, and exploration in post-ASCT maintenance therapy is currently ongoing (NCT01745588). Several retrospective analyses suggest that low-dose pomalidomide may have potential in the maintenance treatment of patients with MM. Therefore, investigators developed a maintenance regimen of low-dose pomalidomide to assess the value of maintenance therapy in MM patients who underwent ASCT or who were not suitable for ASCT. Such regimens may reduce drug toxicity and provide greater clinical benefit for patients with MM.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Hao Zhang
        • Sub-Investigator:
          • Bei Liu, MD
        • Sub-Investigator:
          • Yuancheng Guo
        • Sub-Investigator:
          • Yali Zhang
        • Sub-Investigator:
          • Long Zhao
        • Sub-Investigator:
          • Jinli Jin
        • Sub-Investigator:
          • Yaming Xi, MD
        • Sub-Investigator:
          • Haizhen Ma
        • Sub-Investigator:
          • Juan Cheng, MD
        • Sub-Investigator:
          • Chunxia Liu
        • Sub-Investigator:
          • Mingfeng Jia
        • Sub-Investigator:
          • Zijian Li, MD
        • Sub-Investigator:
          • Ming Li
        • Sub-Investigator:
          • Lina Wang
        • Sub-Investigator:
          • Shengxuan Fan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject diagnosed as initially diagnosed with symptomatic MM by the diagnostic criteria of International Myeloma Working Group(IMWG), aged ≥ 18 years.
  2. Subject undergoing ASCT who have had prior induction therapy for no more than 12 months and whose disease has not progressed within 3 months of ASCT.
  3. Subject who are not candidates for ASCT have reached maximum efficacy after induction and consolidation therapy.
  4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-3.
  5. Serum transaminase levels less than three times the upper limit of normal, serum total bilirubin levels not exceeding 35 umol/L, serum creatinine levels less than 177 umol/L, absolute neutrophil values greater than 1.0 x 10^9/L, and platelet counts greater than 75 x 10^9/L.
  6. Subject of childbearing potential must use two reliable methods of contraception simultaneously or have absolutely no sexual relations with the opposite sex for 4 weeks prior to initiation of treatment, during treatment, during suspension of dosing and for 4 weeks after termination of treatment, and women of childbearing potential agree to perform monthly pregnancy tests until 4 weeks after discontinuation of study drug.
  7. Subject voluntarily enrolled in this study and signed an informed consent form.

Exclusion Criteria:

  1. Subject has 17p-, 1q21 amplification, t(4;14), t(14;16), t(14;20), t(11;14), and p53 mutation.
  2. Subject who, in the judgment of the investigator, cannot tolerate pomalidomide treatment or are allergic to lenalidomide or thalidomide drugs.
  3. Subject with a diagnosis of nonsecretory MM (meaning subjects with completely nonsecretory MM or subjects with a small amount of free light chain but with less than 100 mg/L of affected light chain).
  4. with central nervous system involvement.
  5. subject with peripheral neuropathy ≥ grade 3.
  6. subject with known active hepatitis B virus (HBV-DNA ≥ l × 103 copies/mL or HBV-DNA > 200 IU/mL) or hepatitis C virus (HCV), or serologically positive for human immunodeficiency virus (HIV).
  7. Subject with concurrent other neoplasms or a prior history of neoplasms or antineoplastic therapy (including major surgery) within the last 4 weeks, except for the following neoplastic diseases or those who have lived tumor-free for ≥ 3 years to date: basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage of T1a or T1b) or treated prostate cancer.
  8. Subject with coexisting serious infectious disease.
  9. Subject who refuse to use a reliable form of contraception during pregnancy and lactation or at an appropriate age.
  10. Subject with active new thrombosis or unwilling to undergo antithrombotic therapy.
  11. Subject who, in the opinion of the investigator, are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Primary MM patients started maintenance therapy after 3 months of ASCT or after maximum efficacy was achieved with induction and consolidation therapy. All patients will receive pomalidomide 1 mg daily on days 1 through 21 of each 28-day cycle.
Drug: Pomalidomide
Pomalidomide, 2mg/d, d1-21; treatment cycles every 28days
Other Names:
  • Pomalyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival(2y-PFS)
Time Frame: up to 24 months.
2y-PFS was defined as the proportion of patients who reached at least 2 years from the first day of treatment to the time of disease progression or death.
up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival(2y-OS)
Time Frame: up to 24 months.
2y-OS was defined as the proportion of patients with a time from the first day of treatment to death of at least 2 years.
up to 24 months.
Complete remission(CR)
Time Frame: up to 24 months.
It includes strict complete remission (sCR), CR: negative serum and urine immunofixation electrophoresis and bone marrow plasma cells <5%; sCR: normal serum free light chain ratio and absence of clonal plasma cells in bone marrow confirmed by immunohistochemistry on the basis of meeting CR criteria;
up to 24 months.
very good partial remission(VGPR)
Time Frame: up to 24 months.
VGPR: undetectable M protein by serum protein electrophoresis but still positive by serum and and urine immunofixation electrophoresis, or ≥90% reduction in M protein and urine M protein <100 mg/24h.
up to 24 months.
negative rate of minimal residual disease
Time Frame: up to 24 months.
Flow cytometry was used to detect cells with abnormal immunophenotype, and residual tumor cells <10-4 were considered negative.
up to 24 months.
adverse events
Time Frame: Adverse event reports are collected once a month during treatment, up to 24 months.
number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Adverse event reports are collected once a month during treatment, up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LanZhou University

Collaborators

Beijing Health Alliance Charitable Foundation

Investigators

  • Principal Investigator: Hao Zhang, The First Hospital of Lanzhou University,Lanzhou, Gansu, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POMLDYY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the completion of the clinical trial, we will choose whether to disclose the result according to the relevant regulations of the Chinese Genetic Office.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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