Multiple MyelomaPhase 4NCT05722405
Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
A Phase 4 study testing Ixazomib plus low-dose lenalidomide and Ixazomib in people with Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Ixazomib combined with low-dose lenalidomide(10mg) vs Ixazomib alone as maintenance regimen in patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ixazomib plus low-dose lenalidomide and Ixazomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of symptomatic multiple myeloma with high-risk genetic features (1q21 amplification/t(4;14)/t(14;16)/t(14;20)/17p deletion/TP53 mutation) according to IMWG 2016 criteria.
- ECOG 0-3
- After induction and consolidation of the VRD regimen (where patients younger than 65 years of age who are eligible for autologous HSCT and are willing to undergo autologous HSCT collect stem cells and complete autologous HSCT after 3 courses and continue bortezomib or Ixazomib continuous therapy while awaiting transplantation and complete post-transplant consolidation; patients who are not eligible for HSCT regulation or refuse to undergo autologous HSCT go directly to consolidation after induction therapy) and are willing to receive maintenance therapy.
- Expected survival beyond 6 months
- Age 18 to 80 years.
- Adequate renal, hepatic, pulmonary and cardiac function, defined as follows Creatinine clearance (as estimated by Cockcroft-Gault) ≥ 60 ml/min (except for abnormal renal function due to multiple myeloma).
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- Serum ALT and AST below 2.5 times the upper limit of normal Total bilirubin below 1.5 times the upper limit of normal Cardiac ejection fraction ≥ 50%, no pericardial effusion confirmed by echocardiography, no clinically significant electrocardiographic findings Absence of clinically significant pleural effusion Baseline oxygen saturation ≥ 95% while indoors
- Serum or urine pregnancy tests must be negative in women of childbearing potential (women who have undergone sterilization or are at least 2 years post-menopausal may be considered infertile), and patients treated with lenalidomide should have strict contraception and birth control measures.
- Patients are able to comply with the trial protocol as judged by the investigator.
- Patients voluntarily participate in this clinical trial, understand the study procedures and are able to sign the informed consent in writing.
Who cannot join
- Presence of fungal, bacterial, viral or other infections that are uncontrollable or require IV antimicrobial therapy. Presence of simple urinary tract infection and uncomplicated bacterial pharyngitis, after consultation with the investigator, if responsive to active treatment.
- Known presence of HIV or a history of hepatitis B (HBsAg positive) or viral hepatitis C (anti-HCV positive) infection. A history of treated hepatitis B or hepatitis C is allowed if a viral load undetectable by quantitative PCR and/or nucleic acid testing is present.
- A history of thrombosis within six months.
- presence of a history of malignancy other than carcinoma in situ (e.g., cervical, bladder, breast, thyroid), except in patients who have not had an episode for at least 3 years
- Patients with uncontrolled arrhythmias and a history of myocardial infarction, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.
- The presence of a significant immunodeficiency.
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- The presence of any medical condition that may interfere with the assessment of the safety or efficacy of the investigational treatment.
- A history of severe hypersensitivity reactions to this investigational drug.
- Any pregnant or breastfeeding female of childbearing potential.
- Male and female subjects who are unwilling to use birth control within 6 months from the time of signing the consent form until the completion of the administration of this study.
- Subjects who, in the judgment of the investigator, are unlikely to complete all study visits or procedures required by the protocol, including follow-up visits or compliance with the requirements for participation in the study.
- History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that causes end-organ damage or requires systemic immunosuppressive/systemic disease-modifying drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yang Xu
Hangzhou, Zhejiang, 310009
Yang Xu, MD,PhD, +86-89713674, yxu@zju.edu.cn
Xuzhao Zhang, MD,PhD, 086-15868881531, zxzzju@zju.edu.cn
About this study
Official title: Exploratory Study of Ixazomib in Combination With Reduced Dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
Ixazomib combined with low-dose lenalidomide(10mg) vs Ixazomib alone as maintenance regimen in patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
Read the detailed description
This study was designed to investigate whether the oral proteasome inhibitor ixazomib combined with low-dose lenalidomide(10mg) as a maintenance regimen could improve the outcome and prognosis of patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib plus low-dose lenalidomide, Ixazomib
- Keywords
- high risk multiple myeloma, Ixazomib, low-dose lenalidomide, maintenance therapy
- 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 plus low-dose lenalidomideDrug
Also called Ninlaro
Whether Ixazomib combined with low-dose lenalidomide improves the outcome and prognosis of patients with high-risk multiple myeloma as a maintenance treatment option compared to ixazolomib alone
IxazomibDrug
Also called Ninlaro
Ixazomib alone
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib | Other | Ixazomib as the single drug for maintenance. This group as control arm Receives: Drug: Ixazomib |
| Ixazomib plus low-dose lenalidomide | Experimental | Ixazomib combined with low-dose lenalidomide(10mg) for maintenance Receives: Drug: Ixazomib plus low-dose lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurs first. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Measured: through study completion, a average of 1 year
Secondary outcomes (3)
Very Good Partial Response (VGPR) + Complete Response (CR) Rate
Using IMWG criteria
Measured: through study completion, a average of 1 year
Overall Survival (OS)
OS is measured as the time from the date of first dose of study drug to the date of death.
Measured: through study completion, a average of 1 year
Percentage of Participants with Adverse Events (AEs)
Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug.
Measured: through study completion, a average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, Lishui Country People's Hospital, Dongyang People's Hospital, Shangyu People's Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital
- Responsible party
- Sponsor
- Investigators
- Yang Xu, Dr., Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722405
- Sponsor's protocol ID
- 2022-0215
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Ixazomib in Combination With Reduced Dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05722405
- Acronym / sponsor ID
- 2022-0215
- Conditions
- Multiple Myeloma
- Keywords
- high risk multiple myeloma, Ixazomib, low-dose lenalidomide, maintenance therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, Lishui Country People's Hospital, Dongyang People's Hospital, Shangyu People's Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 10 Feb 2023 (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.
Ixazomib combined with low-dose lenalidomide(10mg) vs Ixazomib alone as maintenance regimen in patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
Detailed description
This study was designed to investigate whether the oral proteasome inhibitor ixazomib combined with low-dose lenalidomide(10mg) as a maintenance regimen could improve the outcome and prognosis of patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixazomib | Other | Drug: IxazomibIxazomib as the single drug for maintenance. This group as control arm |
| Ixazomib plus low-dose lenalidomide | Experimental | Drug: Ixazomib plus low-dose lenalidomideIxazomib combined with low-dose lenalidomide(10mg) for maintenance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a confirmed diagnosis of symptomatic multiple myeloma with high-risk genetic features (1q21 amplification/t(4;14)/t(14;16)/t(14;20)/17p deletion/TP53 mutation) according to IMWG 2016 criteria.
- ECOG 0-3
- After induction and consolidation of the VRD regimen (where patients younger than 65 years of age who are eligible for autologous HSCT and are willing to undergo autologous HSCT collect stem cells and complete autologous HSCT after 3 courses and continue bortezomib or Ixazomib continuous therapy while awaiting transplantation and complete post-transplant consolidation; patients who are not eligible for HSCT regulation or refuse to undergo autologous HSCT go directly to consolidation after induction therapy) and are willing to receive maintenance therapy.
- Expected survival beyond 6 months
- Age 18 to 80 years.
Key exclusion criteria (12 listed)
- Presence of fungal, bacterial, viral or other infections that are uncontrollable or require IV antimicrobial therapy. Presence of simple urinary tract infection and uncomplicated bacterial pharyngitis, after consultation with the investigator, if responsive to active treatment.
- Known presence of HIV or a history of hepatitis B (HBsAg positive) or viral hepatitis C (anti-HCV positive) infection. A history of treated hepatitis B or hepatitis C is allowed if a viral load undetectable by quantitative PCR and/or nucleic acid testing is present.
- A history of thrombosis within six months.
- presence of a history of malignancy other than carcinoma in situ (e.g., cervical, bladder, breast, thyroid), except in patients who have not had an episode for at least 3 years
- Patients with uncontrolled arrhythmias and a history of myocardial infarction, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.
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 plus low-dose lenalidomideAlso: NinlaroWhether Ixazomib combined with low-dose lenalidomide improves the outcome and prognosis of patients with high-risk multiple myeloma as a maintenance treatment option compared to ixazolomib alone | Drug | Ixazomib plus low-dose lenalidomide |
| IxazomibAlso: NinlaroIxazomib alone | Drug | Ixazomib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: through study completion, a average of 1 year
PFS is defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurs first. PD is defined as >=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); bone marrow plasma cell percent >/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
3 secondary outcomes
Very Good Partial Response (VGPR) + Complete Response (CR) Rate
Time frame: through study completion, a average of 1 year
Overall Survival (OS)
Time frame: through study completion, a average of 1 year
Percentage of Participants with Adverse Events (AEs)
Time frame: through study completion, a average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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.
Yang Xu, Dr. study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ixazomib plus low-dose lenalidomide and Ixazomib in people with Multiple Myeloma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuzhao Zhang, Dr. ((086)571-89713679, zxzzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: through study completion, a average of 1 year). 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 5 Jan 2026.