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Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR (very good PR)after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years.
Newly Diagnosed Myeloma Patients, who achieved efficacy above VGPR after initial treatment were enrolled. Patients were then randomly assigned to Id and Rd groups for maintenance treatment. Therapeutic effectiveness will be reviewed monthly until intolerant side effect or disease progression appear . The follow-up period is approximately 2 years. Progression-free survival (PFS)was defined as the duration from randomization to the first evidence of disease progression or death from any cause. Overall survival (OS) was defined as the duration from the randomization to death from any cause. The Kaplan-Meier method was employed to plot the survival curves, with the log-rank test to assess the differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixazomib DX | Experimental | Id: Ixazomib 4mg po d1,8,15; Dexamethasone 20mg po d1,8,15,22; (28 days /cycle). The treatment will be maintained for 2 years (if no disease progression or intolerant side effects appear). |
|
| Lenalidomide DX | Placebo Comparator | Rd: Lenalidomide 25mg qd d1-21; Dexamethasone 20mg po d1,8,15,22; (28 days /cycle). The treatment will be maintained for 2 years (if no disease progression or intolerant side effects appear). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixazomib DX/Lenalidomide DX | Drug | After assessment of risk stratification,patients will be assigned to Id or Rd group randomly for maintenance therapy. Then they will be reviewed the efficacy monthly. |
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of 2 year PFS(progression-free survival) | the percentage of the patients whose disease do not appear progression at the end of 2years maintenance from each group. | from randomization to the end of 2years maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| OS(overall survival) | OS of the either group patients | from duration from the randomization to the end of 2years maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| side effect | side effect of each group within 2 years of maintenance | from randomization to the end of 2years maintenance |
Inclusion Criteria:
Adult male or female patients aged 18 years or older with a confirmed diagnosis of symptomatic diagnosed multiple myeloma. Patients who have previously received initial treatment (induction, transplantation and consolidation are considered to be the same as first-line treatment) and the efficacy assessment ≥VGPR after the initial therapy.
An informed consent form (ICF) has been signed. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family will sign the informed consent;
Female patients of child-bearing potential should meet both of the following criteria:
Male subjects(including those undergo vasectomy) agree to use condoms if sexually active with a female of child-bearing potential from the date of signing the informed consent. And no plan of pregnancy throughout the study and for three months following the last dose.
There are follow-up conditions. The patients known about the characteristics of the disease and voluntarily join the study program for treatment and follow-up.
Complete documentation of of the initial therapy is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Patient is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
Patients must meet the following clinical laboratory criteria at study entry:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Liu | Contact | +86-18918186325 | liujia1798@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Zhong | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| shanghai Jiaotong University School of Medicine, Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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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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Patients were randomly divided into two groups(Id,Rd)after risk stratification.
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|
| 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 |