Clinical Research of Pomalidomide Maintenance Therapy for Primary Multiple Myeloma
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2022
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedOctober 4, 2023
October 1, 2023
3 years
April 21, 2022
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year progression-free survival(2y-PFS)
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 Outcomes (5)
2-year overall survival(2y-OS)
up to 24 months.
Complete remission(CR)
up to 24 months.
very good partial remission(VGPR)
up to 24 months.
negative rate of minimal residual disease
up to 24 months.
adverse events
Adverse event reports are collected once a month during treatment, up to 24 months.
Study Arms (1)
experimental group
EXPERIMENTALPrimary 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.
Interventions
Pomalidomide, 2mg/d, d1-21; treatment cycles every 28days
Eligibility Criteria
You may qualify if:
- Subject diagnosed as initially diagnosed with symptomatic MM by the diagnostic criteria of International Myeloma Working Group(IMWG), aged ≥ 18 years.
- 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.
- Subject who are not candidates for ASCT have reached maximum efficacy after induction and consolidation therapy.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-3.
- 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.
- 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.
- Subject voluntarily enrolled in this study and signed an informed consent form.
You may not qualify if:
- Subject has 17p-, 1q21 amplification, t(4;14), t(14;16), t(14;20), t(11;14), and p53 mutation.
- Subject who, in the judgment of the investigator, cannot tolerate pomalidomide treatment or are allergic to lenalidomide or thalidomide drugs.
- 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).
- with central nervous system involvement.
- subject with peripheral neuropathy ≥ grade 3.
- 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).
- 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.
- Subject with coexisting serious infectious disease.
- Subject who refuse to use a reliable form of contraception during pregnancy and lactation or at an appropriate age.
- Subject with active new thrombosis or unwilling to undergo antithrombotic therapy.
- Subject who, in the opinion of the investigator, are not suitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LanZhou Universitylead
- Beijing Health Alliance Charitable Foundationcollaborator
Study Sites (1)
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Related Publications (8)
Costa LJ, Brill IK, Omel J, Godby K, Kumar SK, Brown EE. Recent trends in multiple myeloma incidence and survival by age, race, and ethnicity in the United States. Blood Adv. 2017 Jan 4;1(4):282-287. doi: 10.1182/bloodadvances.2016002493. eCollection 2017 Jan 10.
PMID: 29296944BACKGROUNDRawstron AC, Child JA, de Tute RM, Davies FE, Gregory WM, Bell SE, Szubert AJ, Navarro-Coy N, Drayson MT, Feyler S, Ross FM, Cook G, Jackson GH, Morgan GJ, Owen RG. Minimal residual disease assessed by multiparameter flow cytometry in multiple myeloma: impact on outcome in the Medical Research Council Myeloma IX Study. J Clin Oncol. 2013 Jul 10;31(20):2540-7. doi: 10.1200/JCO.2012.46.2119. Epub 2013 Jun 3.
PMID: 23733781BACKGROUNDMunshi NC, Avet-Loiseau H, Rawstron AC, Owen RG, Child JA, Thakurta A, Sherrington P, Samur MK, Georgieva A, Anderson KC, Gregory WM. Association of Minimal Residual Disease With Superior Survival Outcomes in Patients With Multiple Myeloma: A Meta-analysis. JAMA Oncol. 2017 Jan 1;3(1):28-35. doi: 10.1001/jamaoncol.2016.3160.
PMID: 27632282BACKGROUNDLiu H, McCarthy P. New developments in post-transplant maintenance treatment of multiple myeloma. Semin Oncol. 2013 Oct;40(5):602-9. doi: 10.1053/j.seminoncol.2013.07.008.
PMID: 24135405BACKGROUNDRios-Tamayo R, Martin-Garcia A, Alarcon-Payer C, Sanchez-Rodriguez D, de la Guardia AMDVD, Garcia Collado CG, Jimenez Morales A, Jurado Chacon M, Cabeza Barrera J. Pomalidomide in the treatment of multiple myeloma: design, development and place in therapy. Drug Des Devel Ther. 2017 Aug 22;11:2399-2408. doi: 10.2147/DDDT.S115456. eCollection 2017.
PMID: 28860711BACKGROUNDRychak E, Mendy D, Shi T, Ning Y, Leisten J, Lu L, Miller K, Narla RK, Orlowski RZ, Raymon HK, Bjorklund CC, Thakurta A, Gandhi AK, Cathers BE, Chopra R, Daniel TO, Lopez-Girona A. Pomalidomide in combination with dexamethasone results in synergistic anti-tumour responses in pre-clinical models of lenalidomide-resistant multiple myeloma. Br J Haematol. 2016 Mar;172(6):889-901. doi: 10.1111/bjh.13905. Epub 2016 Feb 23.
PMID: 26914976BACKGROUNDRichardson PG, Mark TM, Lacy MQ. Pomalidomide: new immunomodulatory agent with potent antiproliferative effects. Crit Rev Oncol Hematol. 2013 Oct;88 Suppl 1:S36-44. doi: 10.1016/j.critrevonc.2013.02.001. Epub 2013 Jun 17.
PMID: 23786844BACKGROUNDAtieh T, Hubben A, Faiman B, Valent J, Samaras CJ, Khouri J. Pomalidomide-based maintenance post-autologous hematopoietic cell transplantation in multiple myeloma: a case series. Ann Hematol. 2019 Oct;98(10):2457-2459. doi: 10.1007/s00277-019-03772-1. Epub 2019 Aug 7. No abstract available.
PMID: 31392460BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hao Zhang
The First Hospital of Lanzhou University,Lanzhou, Gansu, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Subjects and researchers can know which treatment is being used.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master, associate chief physician, Principal Investigator
Study Record Dates
First Submitted
April 21, 2022
First Posted
May 18, 2022
Study Start
May 15, 2022
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
October 4, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
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.