Multiple MyelomaPhase 4NCT04989140
Study of Pomalidomide, Oral Dexamethasone and Ixazomib in Patients With Relapsed MM Who Have Received Lenalidomide
A Phase 4 study testing Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone in people with Multiple Myeloma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ixazomib, oral dexamethasone and in patients with relapsed multiple myeloma who have received lenalidomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to 26 Jul 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years of age or older;
- Newly diagnosed MM patients who fulfill the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020) Standards;
- Patients with relapsed MM who have received 1 to 3 prior therapies (including lenalidomide);
- There must be a washout period of two weeks (14 days) from the last treatment (excluding dexamethasone treatment);
- Previously untreated subjects with ixazomib or pomalidomide;
- Subjects of childbearing age should take effective contraceptive measures and must agree to comply with all contraceptive requirements; Contraceptive requirements: women with fertility must decide to adopt two reliable contraceptive methods at the same time (a highly effective method of contraception-fallopian tube ligation, intrauterine contraceptive device, hormones (contraceptive pills, needles, patches, vaginal rings or implants) ) Or partner's vas deferens ligation, another effective contraceptive program-male rubber or synthetic condoms, diaphragm or cervical cap); unless the cause of hysterectomy, or a history of infertility in time, effective contraception is also required. Men must agree to use a latex condom during sexual contact with a Females of childbearing potential even if they have had a successful vasectomy;
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- Patients must have measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein≥5 g/ L, Urine M-protein≥200 mg/24 hours, Serum free light chain assay: involved free light chain level≥100 mg/L, provided that the serum free light chain ratio is abnormal;
- Hematology satisfies the following conditions: when myeloma cells are less than 50%, ANC≥1.0×109/L (including with the support of G-CSF) and PLT≥75×109/L; when myeloma cells are ≥50% , Any ANC and PLT≥50×109/L;
- Must be able to take antithrombotic drugs, such as low molecular weight heparin sodium or aspirin;
- Physical performance status (ECOG) score ≤ 2; Expected lifetime More than 3 months.
- Patients participate in the study based on his/her own will and voluntarily sign the informed consent form.
Who cannot join
- Patients who are allergic or intolerant to ixazomib, pomalidomide or dexamethasone;
- Patients who have used ixazomib or pomalidomide;
- Patients who are resistant to bortezomib;
- Patients with severe cardiopulmonary insufficiency;
- Patients with severe liver and kidney dysfunction, ALT or AST or bilirubin exceeds 3 times the upper limit of normal range, and the creatinine clearance rate is less than 30 ml/min;
- patients with other malignancies (except for carcinoma in situ);
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- patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
- Patients with active new thrombosis or unwilling to receive anti-thrombotic therapy;
- Patients with extramedullary disease;
- Patients with peripheral neuropathy ≥ Grade 3;
- Pregnant or lactating women;
- Can't strictly contraception;
- Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up;
- Patients who have participated in other clinical trials within one month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PekingUMCH
Beijing, Beijing Municipality, 100005
Junling Zhuang, MD, +86 13910118511, zhuangjunling@hotmail.com
About this study
Official title: A Multi-center, Open-label, Single-arm Clinical Study of Ixazomib/Pomalidomide/Dexamethasone (IxaPD) in the Treatment of Patients With Relapsed Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of ixazomib, oral dexamethasone and in patients with relapsed multiple myeloma who have received lenalidomide.
Read the detailed description
Multiple myeloma (MM), the second most common hematological malignancy, is a clonal plasma cell disorder characterized by the secretion of monoclonal immunoglobulins. The annual incidence of newly diagnosed MM (NDMM) patients is about 2-3/100,000. In the past 20 years, the median overall survival (OS) of MM patients has prolonged from 3 to 5 years to 8 to 10 years since many novel agents developed on the pipeline of treatment. For patients with relapsed/refractory multiple myeloma, the combination of new drugs can prolong the patient's progression-free survival (PFS) and overall survival (OS). At present, guidelines recommend the use of 3-4 drugs combined with chemotherapy containing proteasome inhibitors, immunomodulators or daratumomab for the treatment of patients with relapsed and refractory multiple myeloma treatment.
Bortezomib combined with lenalidomide and dexamethasone (VRd) is the first-line induction program recommended by guidelines; It has been widely used in the first-line treatment of MM patients. Therefore, when the disease relapses, the VRd regimen is not effective again. Research data shows that the second-generation oral proteasome inhibitor drug ixazomib combined with lenalidomide and dexamethasone (IxaRd) is used to treat the disease. In the treatment of RRMM patients, the progression-free survival period was significantly better than that of the lenalidomide and dexamethasone groups, and at the same time, it did not significantly increase the adverse reactions. The second-generation PI drug, Ixazomib, was approved in China in May 2018 and is widely used in RRMM patients. In addition, because most patients with multiple myeloma use lenalidomide in the first-line treatment and maintenance treatment, a large proportion of RRMM patients are resistant to lenalidomide. Pomalidomide, the third-generation oral immunomodulator drug, can overcome lenalidomide resistance and has better safety in patients with renal insufficiency MM. The results of clinical trials confirmed that pomalidomide combined with a proteasome inhibitor and dexamethasone is better than a dual-drug regimen of pomalidomide and dexamethasone in RRMM patients. A convenient and safe full oral regimen, that is, ixazomib combined with pomalidomide and dexamethasone (IxaPd) is expected to improve the efficacy and survival of RRMM patients. The purpose of this study was to evaluate the efficacy and safety of a three-drug oral regimen of ixazomib, pomalidomide and dexamethasone in patients with relapsed MM who have received lenalidomide.
At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria.Eligible patients are receive treatment IxaPD. Ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients >75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity.Progression free survival, overall survival, time to next treatment, overall response rate and safety issues will be recorded. Drug doses will be adjusted or withdrawn based on the degree of toxicities.
- Conditions
- Multiple Myeloma
- Being tested
- Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone
- Keywords
- relapsed MM, oral regiment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Ixazomib Drug:pomalidomide Drug:dexamethasoneDrug
Treatment was continued until disease progression, unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| IxaPD | Experimental | Ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients >75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle. Receives: Drug: Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
From enrollment to first disease progression
Measured: Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months
Secondary outcomes (4)
Adverse events assessment
Number of adverse events according to symptoms, physical examination and scheduled laboratory tests
Measured: Each cycle, up to 24 months of follow-up.
Overall survival
From enrollment to death with follow-up
Measured: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Overall response rate
Overall response rate included Complete Response (CR), Very good partial response (VGPR) and PR, before the new treatment, two consecutive evaluations are in line with defined criteria in order to confirm the efficacy evaluation.
Measured: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Time to next treatment
From enrollment to the time next treatment is administrated
Measured: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start26 Jul 2021
- Primary completion26 Jul 2024 (estimated)
- Study completion26 Jul 2024 (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.
- More trials run by Peking Union Medical College 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Beijing Chao Yang Hospital, Tianjin Medical University General Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital, Beijing Hospital, The First Affiliated Hospital of Anhui Medical University, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University
- Responsible party
- Principal investigator, Junling Zhuang, Peking Union Medical College Hospital
- Investigators
- Junling Zhuang, MD, Principal investigator, Peking UMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989140
- Sponsor's protocol ID
- HS-2883
- Status last verified
- Aug 2021
- First submitted
- 10 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual baseline characteristic ,treatment and follow-up results will be shared after publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Single-arm Clinical Study of Ixazomib/Pomalidomide/Dexamethasone (IxaPD) in the Treatment of Patients With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04989140
- Acronym / sponsor ID
- HS-2883
- Conditions
- Multiple Myeloma
- Keywords
- relapsed MM, oral regiment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Beijing Chao Yang Hospital, Tianjin Medical University General Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital, Beijing Hospital, The First Affiliated Hospital of Anhui Medical University, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 26 Jul 2024 (estimated)
- Study completion
- 26 Jul 2024 (estimated)
- First posted
- 4 Aug 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of ixazomib, oral dexamethasone and in patients with relapsed multiple myeloma who have received lenalidomide.
Detailed description
Multiple myeloma (MM), the second most common hematological malignancy, is a clonal plasma cell disorder characterized by the secretion of monoclonal immunoglobulins. The annual incidence of newly diagnosed MM (NDMM) patients is about 2-3/100,000. In the past 20 years, the median overall survival (OS) of MM patients has prolonged from 3 to 5 years to 8 to 10 years since many novel agents developed on the pipeline of treatment. For patients with relapsed/refractory multiple myeloma, the combination of new drugs can prolong the patient's progression-free survival (PFS) and overall survival (OS). At present, guidelines recommend the use of 3-4 drugs combined with chemotherapy containing proteasome inhibitors, immunomodulators or daratumomab for the treatment of patients with relapsed and refractory multiple myeloma treatment.
Bortezomib combined with lenalidomide and dexamethasone (VRd) is the first-line induction program recommended by guidelines; It has been widely used in the first-line treatment of MM patients. Therefore, when the disease relapses, the VRd regimen is not effective again. Research data shows that the second-generation oral proteasome inhibitor drug ixazomib combined with lenalidomide and dexamethasone (IxaRd) is used to treat the disease. In the treatment of RRMM patients, the progression-free survival period was significantly better than that of the lenalidomide and dexamethasone groups, and at the same time, it did not significantly increase the adverse reactions. The second-generation PI drug, Ixazomib, was approved in China in May 2018 and is widely used in RRMM patients. In addition, because most patients with multiple myeloma use lenalidomide in the first-line treatment and maintenance treatment, a large proportion of RRMM patients are resistant to lenalidomide. Pomalidomide, the third-generation oral immunomodulator drug, can overcome lenalidomide resistance and has better safety in patients with renal insufficiency MM. The results of clinical trials confirmed that pomalidomide combined with a proteasome inhibitor and dexamethasone is better than a dual-drug regimen of pomalidomide and dexamethasone in RRMM patients. A convenient and safe full oral regimen, that is, ixazomib combined with pomalidomide and dexamethasone (IxaPd) is expected to improve the efficacy and survival of RRMM patients. The purpose of this study was to evaluate the efficacy and safety of a three-drug oral regimen of ixazomib, pomalidomide and dexamethasone in patients with relapsed MM who have received lenalidomide.
At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria.Eligible patients are receive treatment IxaPD. Ixazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients >75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity.Progression free survival, overall survival, time to next treatment, overall response rate and safety issues will be recorded. Drug doses will be adjusted or withdrawn based on the degree of toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IxaPD | Experimental | Drug: Drug: Ixazomib Drug:pomalidomide Drug:dexamethasoneIxazomib 4 mg, capsules, orally, once on Days 1, 8 and 15 of every 28-day cycle , pomalidomide 25mg qd day 1~21 of every 28-day cycle, Dexamethasone 40 mg (20 mg for patients >75 years of age) was given on days 1, 8, 15, and 22 of every 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients 18 years of age or older;
- Newly diagnosed MM patients who fulfill the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020) Standards;
- Patients with relapsed MM who have received 1 to 3 prior therapies (including lenalidomide);
- There must be a washout period of two weeks (14 days) from the last treatment (excluding dexamethasone treatment);
- Previously untreated subjects with ixazomib or pomalidomide;
Key exclusion criteria (14 listed)
- Patients who are allergic or intolerant to ixazomib, pomalidomide or dexamethasone;
- Patients who have used ixazomib or pomalidomide;
- Patients who are resistant to bortezomib;
- Patients with severe cardiopulmonary insufficiency;
- Patients with severe liver and kidney dysfunction, ALT or AST or bilirubin exceeds 3 times the upper limit of normal range, and the creatinine clearance rate is less than 30 ml/min;
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 |
|---|---|---|
| Drug: Ixazomib Drug:pomalidomide Drug:dexamethasoneTreatment was continued until disease progression, unacceptable toxicity | Drug | IxaPD |
Primary outcome
Progression-free survival
Time frame: Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months
From enrollment to first disease progression
4 secondary outcomes
Adverse events assessment
Time frame: Each cycle, up to 24 months of follow-up.
Overall survival
Time frame: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Overall response rate
Time frame: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Time to next treatment
Time frame: At baseline, on day 1 of each cycle, and after 2, 3,4,5,7,9,11,13,16,19,22, 25 and 28 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Yes. individual baseline characteristic ,treatment and follow-up results will be shared after publication
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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.
Junling Zhuang, MD principal investigator
Peking UMCH
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 Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone in people with Multiple Myeloma, run by Peking Union Medical College 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 11 inclusion and 14 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 19 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junling Zhuang, MD (13910118511, zhuangjunling@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Time Frame: From date of enrollment until the date of first documented progression, assessed up to 24 months). 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 19 Aug 2021.