Multiple MyelomaPhase 3NCT05236621

A Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma and Recurrent or Refractory, run by Qilu Pharmaceutical Co., Ltd. at 23 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma, Recurrent or Refractory
What is being tested?: Pomalidomide and Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 23 sitesChina
Study dates: 4 Jan 2021to Dec 2023
Phase: Phase 3
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

1.Subjects diagnosed with multiple myeloma according to the diagnostic criteria of Chinese Multiple Myeloma Diagnosis and Treatment Guidelines (Revised in 2020); 2.Must be ≥ 18 years of age,male or female, if the subject is of childbearing age and should use effective contraceptive methods, the subject must agree to comply with all contraceptive requirements:
there are fertile women have to decide, at the same time take two reliable contraceptive methods (an effective contraceptive method is: tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needles, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method is: male or synthetic rubber condom, diaphragm or cervical cap). Unless hysterectomy is performed, effective contraception is required even if there is a history of infertility.
Fertile men must use rubber or synthetic condoms at all times during the use of this product and during sexual contact with fertile women within 28 days of discontinuation of this product, even if participants have successfully had a vasectomy.
3. Received at least two previous treatments (in different treatment regimens or the same regimen, including at least 2 cycles of lenalidomide and 2 cycles of proteasome inhibitors [such as bortezomib or ixazomib]) Relapse of multiple myeloma or ineffective to the last treatment (definition of last treatment ineffective: disease progression during the use of the treatment plan or disease progression within 60 days after the completion of the treatment plan), the last treatment plan is not limited; 4. Multiple myeloma subjects with measurable M protein, i.e., at least one of the following 3 assays:
Serum M protein≥0.5g/dL (5g/L);
Urine M protein≥200mg/24h;

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Determination of serum free light chain: in the case of abnormal serum free light chain ratio, the level of involved free light chain is ≥10 mg/dL (100 mg/L); 5. Hematology meets the following conditions:
1) ANC≥1.0 x10^9/L (including ANC≥1.0x10^9/L supported by G-CSF); 2) PLT≥50 x10^9/L； 3) When plasma cells in bone marrow ≥50%, no specific requirements for neutrophil count, platelet ≥30 x10^9/L can be selected; 6. Liver and kidney function tests meet the following conditions:
TBIL ≤ 2.0mg/dL；
ALT、AST ≤ 3.0 x ULN； 3) Serum creatinine ≤ 3.0 mg/dL or creatinine clearance rate ≥ 30 mL/min; 7. Those who can accept and can use antithrombotic drugs, such as low molecular weight heparin sodium or aspirin; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, expected survival ≥ 3 months; 9. There must be a washout period of ≥ 2 weeks (14 days) from the last treatment (excluding dexamethasone treatment); 10. Subjects voluntarily joined the study and signed a written informed consent.

Who cannot join

Subjects who cannot tolerate thalidomide, lenalidomide, pomalidomide and other types of drug treatment according to the judgment of the investigator.
Subjects who have had allergic reactions to immunomodulators similar to pomalidomide, dexamethasone or components contained in the drug;
Diagnosis of non-secretory MM (non-secretory subjects or subjects with a small amount of free light chain but less than 100mg/L) in multiple myeloma;
Subjects with active new thrombosis or unwilling to undergo antithrombotic therapy;
The subjects are suffering from other tumors at the same time or have a past history of tumors, or have undergone anti-tumor treatment (including major surgery) within the last 4 weeks, except for the following tumor diseases or those who have lived without tumors for ≥ 3 years so far: skin base Cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage T1a or T1b), or treated prostate cancer;
Subjects suffering from central nervous system diseases and requiring treatment;

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Subjects with peripheral neuropathy ≥ grade 3;
Subjects who need to use immunosuppressive or steroid drugs for a long time;
Known subjects with hepatitis B virus (HBV-DNA ≥ 1×10^3 copies/mL or HBV-DNA > 200 IU/mL) or hepatitis C virus (HCV) activity, or human immunodeficiency virus (HIV) ) serologically positive;
Subject has any of the following:
1) According to the NYHA classification standard, cardiac insufficiency grade 2 or above; 2) Myocardial infarction occurred within one year; 3) poorly controlled angina pectoris, including variant angina pectoris; 11. Subjects have serious infectious diseases at the same time; 12. Subjects planning to become pregnant or unable to take reliable contraceptive measures; 13. Women who are pregnant or breastfeeding; 14. Subjects who have received allogeneic hematopoietic stem cell transplantation within 12 months, or who have active graft-versus-host disease (GVHD) or who require immunosuppressive therapy after 12 months of allogeneic hematopoietic stem cell transplantation； 15. Those who participated in other clinical trials and received experimental drugs within one month before the first drug use.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

China23 sites

Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Shengjing Hospital affiliated to China Medical University
Beijing, Beijing Municipality, 100000
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Foshan First People's Hospital
Foshan, Guangdong, 528000
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000
The First Affiliated Hospital of Zhejiang University Medical College (Hematology)
Hangzhou, Zhejiang, 310000
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, 421200
Shandong University Qilu Hospital
Jinan, Shandong, 250000
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000
Weifang People's Hospital
Weifang, Shandong, 261000
Weihai Central Hospital
Weihai, Shandong, 264200
Second Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710000
Henan Tumor Hospital
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Single-Arm Clinical Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD.

Conditions: Multiple Myeloma, Recurrent or Refractory
Being tested: Pomalidomide, Dexamethasone
Keywords: Permadomide capsules
Medical subject headings: Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PomalidomideDrug
4 mg pomalidomide capsules administered orally
DexamethasoneDrug
40 mg dexamethasone tablets administered orally

Study groups in NCT05236621
Study group	Role	What they receive
Permadomide + Low-Dose Dexamethasone	Experimental	Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression. Receives: Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Response Rate(ORR)
Statistical analysis of ORR of primary efficacy will be based on IRC remission assessment results, as well as the investigator's remission assessment.Strict Complete Response (sCR) + Complete Response (CR) + Partial Response (PR) + Very Good PR (VGPR).
Measured: From randomization through the study follow-up phase; up to the data cut-off of 1 December 2023; Maximum time on follow-up was 104 weeks.

Secondary outcomes (3)

Duration of remission(DoR)
The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first.
Measured: The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first, assessed up to 104 weeks.
Progression-free survival(PFS)
The time between the first dose of this trial and the onset of progression (evaluated according to IMWG efficacy criteria listed in the China Guidelines for the Diagnosis and Treatment of Multiple Myeloma 2020 (see attachment)) or death.
Measured: up to 104 weeks
Overall survival(OS)
The time between enrollment for the first dose of the study and the death of the patient from any cause (the last follow-up date for the lost subjects and the end date for the patients who were still alive at the end of the study).
Measured: up to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 2021Dec 2023

First posted11 Feb 2022
Study start4 Jan 2021
Primary completionJun 2022 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 Qilu Pharmaceutical Co., Ltd.The 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05236621
Sponsor's protocol ID: QL-YK4-056-003
Status last verified: Feb 2022
First submitted: 24 Jan 2022
Last updated: 11 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhou H, Wang Y, Chen J, He A, Jin J, Lu Q, Zhao Y, Li J, Hou M, Su L, Lai X, Wang W, Liu L, Ma Y, Gao D, Lai W, Zhou X, Jing H, Zhang J, Yang W, Ran X, Lin C, Hao J, Xiao T, Huang Z, Zhu Z, Wang Q, Fang B, Wang B, Song Y, Cai Z, Liu B, Zhu Y, Yang X, Kang X, Li J, Chen W. Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial. Ann Hematol. 2024 Mar;103(3):855-868. doi: 10.1007/s00277-023-05558-y. Epub 2023 Dec 19.
PubMed 38112795

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Single-Arm Clinical Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05236621
Acronym / sponsor ID: QL-YK4-056-003
Conditions: Multiple Myeloma, Recurrent or Refractory
Keywords: Permadomide capsules
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 85 participants (actual)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Jan 2021 (actual)
Primary completion: Jun 2022 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 11 Feb 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.

The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Permadomide + Low-Dose Dexamethasone	Experimental	Drug: Pomalidomide, Drug: DexamethasoneParticipants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1.Subjects diagnosed with multiple myeloma according to the diagnostic criteria of Chinese Multiple Myeloma Diagnosis and Treatment Guidelines (Revised in 2020); 2.Must be ≥ 18 years of age,male or female, if the subject is of childbearing age and should use effective contraceptive methods, the subject must agree to comply with all contraceptive requirements:
there are fertile women have to decide, at the same time take two reliable contraceptive methods (an effective contraceptive method is: tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needles, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method is: male or synthetic rubber condom, diaphragm or cervical cap). Unless hysterectomy is performed, effective contraception is required even if there is a history of infertility.
Fertile men must use rubber or synthetic condoms at all times during the use of this product and during sexual contact with fertile women within 28 days of discontinuation of this product, even if participants have successfully had a vasectomy.
3. Received at least two previous treatments (in different treatment regimens or the same regimen, including at least 2 cycles of lenalidomide and 2 cycles of proteasome inhibitors [such as bortezomib or ixazomib]) Relapse of multiple myeloma or ineffective to the last treatment (definition of last treatment ineffective: disease progression during the use of the treatment plan or disease progression within 60 days after the completion of the treatment plan), the last treatment plan is not limited; 4. Multiple myeloma subjects with measurable M protein, i.e., at least one of the following 3 assays:
Serum M protein≥0.5g/dL (5g/L);

Key exclusion criteria (11 listed)

Subjects who cannot tolerate thalidomide, lenalidomide, pomalidomide and other types of drug treatment according to the judgment of the investigator.
Subjects who have had allergic reactions to immunomodulators similar to pomalidomide, dexamethasone or components contained in the drug;
Diagnosis of non-secretory MM (non-secretory subjects or subjects with a small amount of free light chain but less than 100mg/L) in multiple myeloma;
Subjects with active new thrombosis or unwilling to undergo antithrombotic therapy;
The subjects are suffering from other tumors at the same time or have a past history of tumors, or have undergone anti-tumor treatment (including major surgery) within the last 4 weeks, except for the following tumor diseases or those who have lived without tumors for ≥ 3 years so far: skin base Cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage T1a or T1b), or treated prostate cancer;

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
Pomalidomide4 mg pomalidomide capsules administered orally	Drug	Permadomide + Low-Dose Dexamethasone
Dexamethasone40 mg dexamethasone tablets administered orally	Drug	Permadomide + Low-Dose Dexamethasone

Primary outcome

Total Response Rate(ORR)
Time frame: From randomization through the study follow-up phase; up to the data cut-off of 1 December 2023; Maximum time on follow-up was 104 weeks.
Statistical analysis of ORR of primary efficacy will be based on IRC remission assessment results, as well as the investigator's remission assessment.Strict Complete Response (sCR) + Complete Response (CR) + Partial Response (PR) + Very Good PR (VGPR).

3 secondary outcomes

Duration of remission(DoR)
Time frame: The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first, assessed up to 104 weeks.
Progression-free survival(PFS)
Time frame: up to 104 weeks
Overall survival(OS)
Time frame: up to 104 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
Derived from this study: PubMed 38112795Zhou H, Wang Y, Chen J, He A, Jin J, Lu Q, Zhao Y, Li J, Hou M, Su L, Lai X, Wang W, Liu L, Ma Y, Gao D, Lai W, Zhou X, Jing H, Zhang J, Yang W, Ran X, Lin C, Hao J, Xiao T, Huang Z, Zhu Z, Wang Q, Fang B, Wang B, Song Y, Cai Z, Liu B, Zhu Y, Yang X, Kang X, Li J, Chen W. Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial. Ann Hematol. 2024 Mar;103(3):855-868. doi: 10.1007/s00277-023-05558-y. Epub 2023 Dec 19.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
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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.

Wenming Chen, MD, PhD principal investigator

Beijing Chao Yang Hospital

Juan Li, MD, PhD principal investigator

First Affiliated Hospital, Sun Yat-Sen University

Hongmei Jing, MD, PhD principal investigator

Peking University Third Hospital

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma and Recurrent or Refractory, run by Qilu Pharmaceutical Co., Ltd. at 23 sites 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 11 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Total Response Rate(ORR) (time frame: From randomization through the study follow-up phase; up to the data cut-off of 1 December 2023; Maximum time on follow-up was 104 weeks.). 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 NCT05236621, which also lists 1 linked publication.

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 11 Feb 2022.