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| Name | Class |
|---|---|
| Beijing Health Alliance Charitable Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug | Pomalidomide, 2mg/d, d1-21; treatment cycles every 28days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival(2y-OS) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Zhang | Contact | +86 13008706320 | 13008706320@189.cn | |
| Bei Liu, MD | Contact | +86 13809319379 | liubeiff@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hao Zhang | The First Hospital of Lanzhou University,Lanzhou, Gansu, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29296944 | Background | 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. | |
| 23733781 | Background | Rawstron 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. |
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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.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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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.
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Subjects and researchers can know which treatment is being used.
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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) | 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 | 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 | 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. |
| 27632282 | Background | Munshi 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. |
| 24135405 | Background | Liu 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. |
| 28860711 | Background | Rios-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. |
| 26914976 | Background | Rychak 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. |
| 23786844 | Background | Richardson 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. |
| 31392460 | Background | Atieh 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. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |