Multiple MyelomaPhase 4NCT04217967
Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients
A Phase 4 study testing Ixazomib and Lenalidomide 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 real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China. 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?
- Ixazomib and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2019to 30 Jun 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
- Age older than 18 years;
- Newly diagnosed MM patients who fulfill the diagnostic criteria of International Myeloma Working Group (IMWG) 2014 standard; transplant-ineligible or transplant eligible yet without intent for ASCT
- Maintenance treatment will start after first-line treatment or second-line treatment;
- The total courses of front-line regimens are between 4-9;
- The clinical efficacy before the enrollment is partial response (PR) or better;
- Physical performance status (ECOG) score ≤ 2;
- 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 or lenalidomide;
- patients with severe cardiopulmonary dysfunction;
- patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
- patients with other malignancies (except for carcinoma in situ);
- patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
- pregnant or lactating women;
- can not be strictly contraceptive;
- Psychiatric patients and patients with other serious mental illness that potentially impact signing informed consent and disease consultation and follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Prospective Study of Ixazomib, Lenalidomide, and Ixazomib in Combination With Lenalidomide for Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to evaluate the real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China.
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. Moreover, multi-drug combination chemotherapy, low-intensity maintenance therapy after achieving a certain effect also contributed to improving the progression-free survival (PFS) and OS in MM patients. Therefore, many international guidelines have explicitly recommended maintenance therapy after first-line regimens until disease progression.
Common maintenance medications include immunomodulatory drugs (IMiDs) such as lenalidomide, thalidomide, ect; proteasome inhibitors (PIs) such as bortezomib. Among them, lenalidomide has the most reliable data as maintenance therapy for prolonging PFS. Although bortezomib maintenance has shown advantages in high-risk MM patients in some clinical trials, it has poor compliance in the real world due to the injection mode of administration and peripheral neuropathy (PN) after long-term use. There is currently no data on the maintenance of large-scale cases in China. The maintenance of regimens in the real world is not standardized, including drug dosage and duration of application. In addition, due to the high cost of bortezomib or lenalidomide for long-term application, domestic thalidomide still accounts for a certain proportion, but its side effects especially PN are very prominent. In addition to the proven efficacy, MM maintenance treatments should preferably include good tolerability, manageable toxicities and administration convenience.
The second-generation PI drug, Ixazomib, was approved in China in May 2018. Based on the data of TOURMALINE MM1 trial and China extended study, ixazomib was approved for the treatment of relapsed and refractory MM. Further more, recent maintenance study after autologous transplantation (MM3) suggested that ixazomib significantly prolonged PFS for 6 months compared with placebo. Because ixazomib is an oral form with a few side effects, especially less PN than bortezomib, safety data and compliance of ixazomib in the real world were comparable as those in the clinical trials.
The survival of patients with multiple myeloma in China is worse than that of western countries. One of the important reasons is irregular follow-up and nonstandard maintenance therapies. Many Chinese MM patients still use traditional maintenance drug thalidomide, which is difficult to apply for a long time due to toxicities especially PN and gastrointestinal reactions. The second generation IMiD drug lenalidomide as maintenance treatment has been increasingly accepted by patients and hematologists. However, due to the low proportion of autologous stem cell transplantation (ASCT) after first-line regimens in China, the efficacy of single-agent maintenance is also limited, especially for high-risk patients. As novel anti-myeloma drugs were rapidly approved and reimbursed in China, a dual oral maintenance regimen of lenalidomide in combination with ixazomib is being explored.
The purpose of this multi-centered study is to evaluate the real world efficacy and safety of the maintenance therapies in Chinese patients with newly diagnosed multiple myeloma (NDMM), non-transplant; which include ixazomib monotherapy, ixazomib combined with lenalidomide, and lenalidomide monotherapy.
Adult NDMM patients who acquire at least partial response (PR) after 4~9 cycles of front-line regimens including ASCT will be recruited. Those who do not reach a PR after 4 cycles of front-line regimens will be switched to the second regimen for at most 5 cycles. After reaching a PR, these patients will also be recruited to the study. Maintenance therapies will be classified into three groups depending on patients' and doctors' discretion, including ixazomib 4mg day 1, 8,15; lenalidomide 25mg qod day 1~21; ixazomib and lenalidomide combination with same doses. Front-line maintenance is given till disease progression. Progression free survival and safety issues will be recorded. Drug doses will be adjusted or withdrawn based on the degree of toxicities.
Adjunctive treatments are prophylaxis of herpes zosters with acyclovir, prophylaxis of venous thrombotic events with aspirin, prophylaxis of high-risk infections with sulfanilamide. The doses of lenalidomide are adjusted depending on clearance of creatinine.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Lenalidomide
- Keywords
- real-world, dual-drug maintenance, oral regimen
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
the ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group
LenalidomideDrug
the lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide group | Active comparator | lenalidomide 25mg qod d1~21 days, rest 7 days Receives: Drug: Lenalidomide |
| Ixazomib group | Active comparator | ixazomib 4mg orally, once a week, 3 times a month Receives: Drug: Ixazomib |
| Combination group | Experimental | ixazomib 4mg orally, once a week, 3 times a month lenalidomide 25mg qod d1~21 days, rest 7 days use in combination Receives: Drug: Ixazomib; Drug: Lenalidomide |
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: From date of enrollment until the date of first documented progression, assessed up to 20 months
overall survival
from enrollment to death with follow-up
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start24 Sep 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Jishuitan Hospital, Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Peking University First Hospital, Jilin Provincial Tumor Hospital, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Shanxi Medical University, Tianjin Medical University General Hospital, The First Affiliated Hospital of Anhui Medical University, Shanxi Bethune Hospital, Beijing Hospital
- Responsible party
- Principal investigator, Junling Zhuang, Peking Union Medical College Hospital
- Investigators
- Junling Zhuang, MD, Principal investigator, Peking Union Medical College, department of hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217967
- Sponsor's protocol ID
- ZS-2129
- Status last verified
- Jul 2024
- First submitted
- 1 Jan 2020
- Last updated
- 1 Aug 2024
- 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
Publications
Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.
PubMed 21410373Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PubMed 19474385Anderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625.
PubMed 28151709Gay F, Jackson G, Rosinol L, Holstein SA, Moreau P, Spada S, Davies F, Lahuerta JJ, Leleu X, Bringhen S, Evangelista A, Hulin C, Panzani U, Cairns DA, Di Raimondo F, Macro M, Liberati AM, Pawlyn C, Offidani M, Spencer A, Hajek R, Terpos E, Morgan GJ, Blade J, Sonneveld P, San-Miguel J, McCarthy PL, Ludwig H, Boccadoro M, Mateos MV, Attal M. Maintenance Treatment and Survival in Patients With Myeloma: A Systematic Review and Network Meta-analysis. JAMA Oncol. 2018 Oct 1;4(10):1389-1397. doi: 10.1001/jamaoncol.2018.2961.
PubMed 30098165Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.
PubMed 30545780Chakraborty R, Muchtar E, Kumar SK, Buadi FK, Dingli D, Dispenzieri A, Hayman SR, Hogan WJ, Kapoor P, Lacy MQ, Leung N, Warsame R, Kourelis T, Gonsalves W, Gertz MA. Outcomes of maintenance therapy with lenalidomide or bortezomib in multiple myeloma in the setting of early autologous stem cell transplantation. Leukemia. 2018 Mar;32(3):712-718. doi: 10.1038/leu.2017.256. Epub 2017 Aug 14.
PubMed 28848227Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Rajkumar SV, Richardson PG. Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance. Leukemia. 2019 Jul;33(7):1736-1746. doi: 10.1038/s41375-019-0384-1. Epub 2019 Jan 29.
PubMed 30696949
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Prospective Study of Ixazomib, Lenalidomide, and Ixazomib in Combination With Lenalidomide for Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04217967
- Acronym / sponsor ID
- ZS-2129
- Conditions
- Multiple Myeloma
- Keywords
- real-world, dual-drug maintenance, oral regimen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Jishuitan Hospital, Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Peking University First Hospital, Jilin Provincial Tumor Hospital, Second Hospital of Shanxi Medical University, The First Affiliated Hospital of Shanxi Medical University, Tianjin Medical University General Hospital, The First Affiliated Hospital of Anhui Medical University, Shanxi Bethune Hospital, Beijing Hospital
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jan 2020 (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 real-world efficacy and safety of ixazomib, lenalidomide, or ixazomib in combination with lenalidomide as maintenance therapy in patients with newly diagnosed multiple myeloma in China.
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. Moreover, multi-drug combination chemotherapy, low-intensity maintenance therapy after achieving a certain effect also contributed to improving the progression-free survival (PFS) and OS in MM patients. Therefore, many international guidelines have explicitly recommended maintenance therapy after first-line regimens until disease progression.
Common maintenance medications include immunomodulatory drugs (IMiDs) such as lenalidomide, thalidomide, ect; proteasome inhibitors (PIs) such as bortezomib. Among them, lenalidomide has the most reliable data as maintenance therapy for prolonging PFS. Although bortezomib maintenance has shown advantages in high-risk MM patients in some clinical trials, it has poor compliance in the real world due to the injection mode of administration and peripheral neuropathy (PN) after long-term use. There is currently no data on the maintenance of large-scale cases in China. The maintenance of regimens in the real world is not standardized, including drug dosage and duration of application. In addition, due to the high cost of bortezomib or lenalidomide for long-term application, domestic thalidomide still accounts for a certain proportion, but its side effects especially PN are very prominent. In addition to the proven efficacy, MM maintenance treatments should preferably include good tolerability, manageable toxicities and administration convenience.
The second-generation PI drug, Ixazomib, was approved in China in May 2018. Based on the data of TOURMALINE MM1 trial and China extended study, ixazomib was approved for the treatment of relapsed and refractory MM. Further more, recent maintenance study after autologous transplantation (MM3) suggested that ixazomib significantly prolonged PFS for 6 months compared with placebo. Because ixazomib is an oral form with a few side effects, especially less PN than bortezomib, safety data and compliance of ixazomib in the real world were comparable as those in the clinical trials.
The survival of patients with multiple myeloma in China is worse than that of western countries. One of the important reasons is irregular follow-up and nonstandard maintenance therapies. Many Chinese MM patients still use traditional maintenance drug thalidomide, which is difficult to apply for a long time due to toxicities especially PN and gastrointestinal reactions. The second generation IMiD drug lenalidomide as maintenance treatment has been increasingly accepted by patients and hematologists. However, due to the low proportion of autologous stem cell transplantation (ASCT) after first-line regimens in China, the efficacy of single-agent maintenance is also limited, especially for high-risk patients. As novel anti-myeloma drugs were rapidly approved and reimbursed in China, a dual oral maintenance regimen of lenalidomide in combination with ixazomib is being explored.
The purpose of this multi-centered study is to evaluate the real world efficacy and safety of the maintenance therapies in Chinese patients with newly diagnosed multiple myeloma (NDMM), non-transplant; which include ixazomib monotherapy, ixazomib combined with lenalidomide, and lenalidomide monotherapy.
Adult NDMM patients who acquire at least partial response (PR) after 4~9 cycles of front-line regimens including ASCT will be recruited. Those who do not reach a PR after 4 cycles of front-line regimens will be switched to the second regimen for at most 5 cycles. After reaching a PR, these patients will also be recruited to the study. Maintenance therapies will be classified into three groups depending on patients' and doctors' discretion, including ixazomib 4mg day 1, 8,15; lenalidomide 25mg qod day 1~21; ixazomib and lenalidomide combination with same doses. Front-line maintenance is given till disease progression. Progression free survival and safety issues will be recorded. Drug doses will be adjusted or withdrawn based on the degree of toxicities.
Adjunctive treatments are prophylaxis of herpes zosters with acyclovir, prophylaxis of venous thrombotic events with aspirin, prophylaxis of high-risk infections with sulfanilamide. The doses of lenalidomide are adjusted depending on clearance of creatinine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide group | Active comparator | Drug: Lenalidomidelenalidomide 25mg qod d1~21 days, rest 7 days |
| Ixazomib group | Active comparator | Drug: Ixazomibixazomib 4mg orally, once a week, 3 times a month |
| Combination group | Experimental | Drug: Ixazomib, Drug: Lenalidomideixazomib 4mg orally, once a week, 3 times a month lenalidomide 25mg qod d1~21 days, rest 7 days use in combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age older than 18 years;
- Newly diagnosed MM patients who fulfill the diagnostic criteria of International Myeloma Working Group (IMWG) 2014 standard; transplant-ineligible or transplant eligible yet without intent for ASCT
- Maintenance treatment will start after first-line treatment or second-line treatment;
- The total courses of front-line regimens are between 4-9;
- The clinical efficacy before the enrollment is partial response (PR) or better;
Key exclusion criteria (8 listed)
- Patients who are allergic or intolerant to ixazomib or lenalidomide;
- patients with severe cardiopulmonary dysfunction;
- patients with severe hepatic insufficiency, ALT or bilirubin more than 2 times the upper limits of normal range;
- patients with other malignancies (except for carcinoma in situ);
- patients with serious bacterial or viral infections, such as HIV or HBV, HCV, etc.;
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 |
|---|---|---|
| Ixazomibthe ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group | Drug | Combination group, Ixazomib group |
| Lenalidomidethe lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib | Drug | Combination group, Lenalidomide group |
Primary outcome
progression-free survival
Time frame: From date of enrollment until the date of first documented progression, assessed up to 20 months
from enrollment to first disease progression
overall survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
from enrollment to death with follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 21410373Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.
- Background: PubMed 19474385Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
- Background: PubMed 28151709Anderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625.
- Background: PubMed 30098165Gay F, Jackson G, Rosinol L, Holstein SA, Moreau P, Spada S, Davies F, Lahuerta JJ, Leleu X, Bringhen S, Evangelista A, Hulin C, Panzani U, Cairns DA, Di Raimondo F, Macro M, Liberati AM, Pawlyn C, Offidani M, Spencer A, Hajek R, Terpos E, Morgan GJ, Blade J, Sonneveld P, San-Miguel J, McCarthy PL, Ludwig H, Boccadoro M, Mateos MV, Attal M. Maintenance Treatment and Survival in Patients With Myeloma: A Systematic Review and Network Meta-analysis. JAMA Oncol. 2018 Oct 1;4(10):1389-1397. doi: 10.1001/jamaoncol.2018.2961.
- Background: PubMed 30545780Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.
- Background: PubMed 28848227Chakraborty R, Muchtar E, Kumar SK, Buadi FK, Dingli D, Dispenzieri A, Hayman SR, Hogan WJ, Kapoor P, Lacy MQ, Leung N, Warsame R, Kourelis T, Gonsalves W, Gertz MA. Outcomes of maintenance therapy with lenalidomide or bortezomib in multiple myeloma in the setting of early autologous stem cell transplantation. Leukemia. 2018 Mar;32(3):712-718. doi: 10.1038/leu.2017.256. Epub 2017 Aug 14.
- Background: PubMed 30696949Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Rajkumar SV, Richardson PG. Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance. Leukemia. 2019 Jul;33(7):1736-1746. doi: 10.1038/s41375-019-0384-1. Epub 2019 Jan 29.
- 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 Union Medical College, department of hematology
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 and Lenalidomide 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 1 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: From date of enrollment until the date of first documented progression, assessed up to 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217967, which also lists 7 linked publications.
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 1 Aug 2024.