Progression Free SurvivalNCT05477797
Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma.
A study testing Ixazomib DX/Lenalidomide DX in people with Progression Free Survival and Overall Survival, run by RenJi Hospital at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Progression Free Survival, Overall Survival, Maintenance
- What is being tested?
- Ixazomib DX/Lenalidomide DX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2023to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Take effective contraceptive measures during the study and for three months following the last dose;
- A negative serum pregnancy test at screening. Note: Women of childbearing potential include all the female who have started menstruating and are not post-menopausal and have not undergone surgical sterilization(eg, hysterectomy, double tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for more than 12 consecutive months due to unspecified reasons.
- 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.
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- 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.
- Details of the state treatment and remission
- cytogenetics at diagnosis
- R-ISS staging at diagnosis
- 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:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 without growth factor support. Platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before randomization.
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
- Alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN.
- Calculated creatinine clearance ≥ 30 mL/min (using the Cockcroft-Gault equation.
Who cannot join
- Multiple myeloma that has relapsed after initial therapy.
- Radiotherapy or major surgery within 14 days before randomization.
- Diagnosed or treated for another malignancy within 1 years before randomization or previous diagnosis with another malignancy with evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Infection requiring IV antibiotic therapy or other serious infection within 14 days before randomization.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina.
- Systemic treatment with strong CYP3A inducers(rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) .
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- Ongoing or active infection, known human immunodeficiency virus positive, active hepatitis B or C infection.
- Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (e.g., PN of any cause that is Grade 1 with pain or Grade 2 or higher).
- Psychiatric illness/social situation that would limit compliance with study requirements.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or GI procedure that could interfere with the oral absorption or tolerance of treatment.
- Treatment with any investigational products within 30 days before randomization.
- Female patient who is lactating and breastfeeding or has a positive serum pregnancy test during the Screening period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality
Jia Liu, 18918186325, liujia1798@renji.com
About this study
Official title: Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma: a Prospective, Randomized, Controlled, Multicenter Clinical Study
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.
Read the detailed description
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.
- Conditions
- Progression Free Survival, Overall Survival, Maintenance
- Being tested
- Ixazomib DX/Lenalidomide DX
- Keywords
- multiple myeloma;, maintenance
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixazomib DX/Lenalidomide DXDrug
Also called Id/Rd
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.
| Study group | Role | What they receive |
|---|---|---|
| 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）. Receives: Drug: Ixazomib DX/Lenalidomide DX |
| 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）. Receives: Drug: Ixazomib DX/Lenalidomide DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from randomization to the end of 2years maintenance.
Secondary outcomes (1)
OS(overall survival)
OS of the either group patients
Measured: from duration from the randomization to the end of 2years maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start16 Feb 2023
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression Free SurvivalStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly divided into two groups（Id，Rd）after risk stratification.
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Zhong, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477797
- Sponsor's protocol ID
- KY2022-029-B
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma: a Prospective, Randomized, Controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05477797
- Acronym / sponsor ID
- KY2022-029-B
- Conditions
- Progression Free Survival, Overall Survival, Maintenance
- Keywords
- multiple myeloma;, maintenance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly divided into two groups（Id，Rd）after risk stratification.
| Arm | Type | Receives |
|---|---|---|
| Ixazomib DX | Experimental | Drug: Ixazomib DX/Lenalidomide DXId: 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 | Drug: Ixazomib DX/Lenalidomide DXRd: 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）. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (13 listed)
- Multiple myeloma that has relapsed after initial therapy.
- Radiotherapy or major surgery within 14 days before randomization.
- Diagnosed or treated for another malignancy within 1 years before randomization or previous diagnosis with another malignancy with evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Infection requiring IV antibiotic therapy or other serious infection within 14 days before randomization.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixazomib DX/Lenalidomide DXAlso: Id/RdAfter 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. | Drug | Ixazomib DX, Lenalidomide DX |
Primary outcome
the percentage of 2 year PFS(progression-free survival)
Time frame: from randomization to the end of 2years maintenance.
the percentage of the patients whose disease do not appear progression at the end of 2years maintenance from each group.
1 secondary outcome
OS(overall survival)
Time frame: from duration from the randomization to the end of 2years maintenance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Zhong principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ixazomib DX/Lenalidomide DX in people with Progression Free Survival and Overall Survival, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Liu (+86-18918186325, liujia1798@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of 2 year PFS(progression-free survival) (time frame: from randomization to the end of 2years maintenance.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.