Multiple MyelomaPhase 2NCT05432414
PVd Versus Vd in NDMM Patients With RI
A Phase 2 study testing pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by RenJi Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide \& Bortezomib \& Dexamethasone) versus VD regimen (Bortezomib \& Dexamethasone) in NDMM patients with RI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- pomalidomide, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2022to 31 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initial diagnosis of symptomatic multiple myeloma (according to the International Myeloma Working Group [IMWG] diagnostic criteria)
- Men and women aged ≥18 years and ≤75 years
- Multiple myeloma patients with measurable M protein should meet at least one of the following three tests: 1) Serum M protein ≥10 g/L; 2) Urinary M protein ≥200 mg/24h; 3) In the case of abnormal serum free light chain ratio, the level of affected free light chain ≥100 mg/L
- No prior treatment for multiple myeloma
- ECOG score ≤2, and predicted survival ≥3 months
- Clinically diagnosed multiple myeloma-related renal injury with calculated or measured creatinine clearance (CrCl)≥15 mL/min and < 60 mL/min (excluding patients undergoing dialysis). The calculated CrCl should be calculated using the widely accepted formula (i.e. Cockcroft-gault formula) :([140-Age] × body weight [kg] / [72 × creatinine mg/dL]); If the subject is female, multiply the result by 0.85 (1mg/dL=88.4umol/L)
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- Hematology: When myeloma cells < 50%, ANC≥1.0×109/L (including with g-CSF support) and PLT≥75×109/L; Myeloma cells ≥50%, any ANC and PLT≥30×109/L; Adjusted serum calcium level ≤3.4 mmol/L; Hemoglobin level ≥8 g/dL
- For the use of symptomatic and supportive therapy only, the biochemical requirements of 6 and 7 achieved by non-myeloma treatment drugs can also be included in the group
- Liver, heart and other major organs meet the requirements of the following laboratory examination indicators (conducted within 7 days before treatment): 1) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) Aspartate aminotransferase (AST) and alanine transferine (ALT) ≤ 1.5 times the upper limit of normal value (same age); 3) myocardial enzymes < 2 times the upper limit of normal value; 4) Echocardiography (ECHO) determined that cardiac ejection fraction was within the normal range.
- Patients with inactive hepatitis and total bilirubin, AST and ALT meeting the inclusion criteria, but HBV-DNA≥104, are recommended to be treated with entecavir and other antiviral drugs, and the treatment course will be determined by researchers after their own evaluation of the patient's situation
- Women of reproductive age (FCBP) subjects must have a negative serum pregnancy test 21 days prior to enrollment and consent to use a valid contraceptive method during all study medications and within 30 days after the last study medication (pregnancy tests may be performed more frequently if local guidelines are followed). FCBP is defined in this protocol as sexually mature women who: 1) have not undergone hysterectomy, bilateral oophorectomy or bilateral salpingectomy, or 2) have not experienced spontaneous menopause for at least 24 consecutive months (i.e., have had menstruation at any time in the previous 24 consecutive months)
- If having sex with FCBP, male subjects must use an effective barrier method of contraception during the study period and for 3 months after the last study drug. Male subjects were not allowed to donate sperm during treatment and for 90 days after the last study drug. Male subjects whose partners are pregnant must abstain from sex or use condoms during vaginal intercourse
- Clearly understand the test content, voluntarily participate in and complete the test, and sign the informed consent. Informed consent was signed by the patient himself or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to treatment, the informed consent shall be signed by the legal guardian or the patient's immediate family member
- Those who can receive and use antithrombotic drugs, such as low-molecular-weight heparin sodium or aspirin, etc.
Who cannot join
- Primary renal disease or secondary renal injury not related to multiple myeloma, such as diabetes
- Prior treatment for myeloma (excluding radiation, bisphosphonates, or a single short-term hormone therapy [i.e., a 4-day dose less than or equivalent to dexamethasone 40mg/ day])
- Non-active multiple myeloma, including MGUS and smoking myeloma
- Prior malignancies requiring treatment or with evidence of recurrence in the 5 years prior to the first study [excluding basal cell carcinoma of the skin and the following carcinomas in situ: Squamous cell carcinoma, carcinoma in situ of bladder, carcinoma in situ of endometrium, carcinoma in situ of cervix/dysplasia, occasional histological discovery of prostate cancer (TNM stage T1a or T1b) or carcinoma in situ of breast]
- Patients with renal insufficiency accompanied by dialysis (excluding those who had received dialysis treatment due to renal insufficiency in the early stage but had not received anti-MM treatment and were not on dialysis at the time of enrollment)
- Active hepatitis A, B, C infection or known HCV RNA positive
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- Known to be HIV positive
- Active infections that are not under control
- History of VTE or cerebral infarction before treatment
- Patients had uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, NYHA defined class ⅲ - ⅳ heart failure, uncontrolled angina, congestive heart failure, clinically significant pericardial disease, or cardiac amyloidosis (NT-Pro-BNP≥1800pg/mL)
- Patients who received major operations within 30 days before the enrollment, which would cause significant physical decline and increased risk of thrombosis, or the operations were scheduled during the study period. Participants who planned to undergo surgery under local anesthesia that would not significantly affect the patient's physical performance or significantly increase the risk of thrombosis could participate in the study
- The proportion of peripheral plasma cells ≥5%, and/or the absolute value of peripheral plasma cells ≥0.5×109/L
- Subjects are pregnant or lactating women
- Uncontrolled high blood pressure or uncontrolled diabetes
- Allergic to borate, mannose, and thalidomide
- According to the protocol or the investigator's judgment, the patient's serious physical or mental illness may interfere with the clinical study participation; Substance abuse, medical, psychological, or social conditions that may interfere with subjects' participation in the study or evaluation of study results
- Patients receiving other experimental drugs
- Participants in other clinical trials within one month
- Any patients deemed unsuitable for inclusion by other investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120
Hou Jian, Phd, 02168383144, houjian@medmail.com.cn
About this study
Official title: Pomalidomide, Bortezomib and Dexamethasone (PVd) Versus Bortezomib and Dexamethasone (Vd) in NDMM Patients With Renal Injury (RI)：A Multicenter, Randomized Controlled, Open-label Trial.
This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide \& Bortezomib \& Dexamethasone) versus VD regimen (Bortezomib \& Dexamethasone) in NDMM patients with RI. The main efficacy indicator is VGPR after 4 cycles of induction therapy.
- Conditions
- Multiple Myeloma
- Being tested
- pomalidomide, Bortezomib, Dexamethasone
- Keywords
- NDMM with RI
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomalidomideDrug
Also called CC-4047
Pomalidomide was administered orally at a dose of 4 mg on days 1-14 of each cycle.
BortezomibDrug
Bortezomib was administered intravenously or subcutaneously at a dose of 1.3mg/m2 on days 1, 4, 8, 11 of each cycle.
DexamethasoneDrug
Dexamethasone was administered orally at a dose of 20mg on days the same and next day of bortezomib administration.
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide, Bortezomib and Dexamethasone (PVD) | Experimental | Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. Receives: Drug: pomalidomide; Drug: Bortezomib; Drug: Dexamethasone |
| Bortezomib and Dexamethasone (VD) | Active comparator | Each cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. Receives: Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥very good partial response
The sum of a complete response and a very good partial response
Measured: At end of cycle 4 (each cycle is 21 days)
Secondary outcomes (4)
MRD negative rate
When patients reached CR, NGF was used to detect the proportion of patients with bone marrow clonoplasma cells without phenotypic abnormalities. The minimum detection sensitivity was 1 clonoplasma cell in 10000 nucleated cells
Measured: From randomization to the date of first documented evidence of PD until study completion, an average of 1.5 year
immunologic function
Twelve cytokine assays, lymphocyte subsets and absolute count, Treg cell assays, lymphocyte activation marker assays, TH1/TH2/TH17 subsets of cytokines assays
Measured: At day 1±3 of cycle 2-5 (each cycle is 21 days)
renal tubular function
Renal remission rate was evaluated according to the 2016 IMWG expert consensus on MM renal injury
Measured: At day 1±3 of cycle 2-5 (each cycle is 21 days)
safety（Number of adverse events ）
Number of adverse events according to symptoms, physical examination and scheduled laboratory tests
Measured: Each cycle (each cycle is 21 days), up to 24 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 posted27 Jun 2022
- Study start8 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (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 RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2(PVD):1(VD) random inclusion
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Shanghai Changzheng Hospital, Shanghai 6th People's Hospital, Peking University Shenzhen Hospital, The Third People's Hospital of Chengdu, The First Affiliated Hospital with Nanjing Medical University, Ningbo No. 1 Hospital, The First Affiliated Hospital of Nanchang University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Jian Hou, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432414
- Sponsor's protocol ID
- POM-MM-003
- Status last verified
- Jan 2023
- First submitted
- 6 Jun 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao F, Wang L, Li F, Wang F, Zhong Y, Qu X, Chang C, Li Z, Liu Y, Dou X, Wen L, Peng N, Lu J, Hou J. Pomalidomide plus bortezomib and dexamethasone for newly diagnosed multiple myeloma with renal impairment: Randomized phase II study (POM-MM-003). Med. 2026 Sep 9:101293. doi: 10.1016/j.medj.2026.101293. Online ahead of print.
PubMed 42716009
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomalidomide, Bortezomib and Dexamethasone (PVd) Versus Bortezomib and Dexamethasone (Vd) in NDMM Patients With Renal Injury (RI)：A Multicenter, Randomized Controlled, Open-label Trial.
- ClinicalTrials.gov ID
- NCT05432414
- Acronym / sponsor ID
- POM-MM-003
- Conditions
- Multiple Myeloma
- Keywords
- NDMM with RI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Shanghai Changzheng Hospital, Shanghai 6th People's Hospital, Peking University Shenzhen Hospital, The Third People's Hospital of Chengdu, The First Affiliated Hospital with Nanjing Medical University, Ningbo No. 1 Hospital, The First Affiliated Hospital of Nanchang University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jun 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.
This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide \& Bortezomib \& Dexamethasone) versus VD regimen (Bortezomib \& Dexamethasone) in NDMM patients with RI. The main efficacy indicator is VGPR after 4 cycles of induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2(PVD):1(VD) random inclusion
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide, Bortezomib and Dexamethasone (PVD) | Experimental | Drug: pomalidomide, Drug: Bortezomib, Drug: DexamethasoneEach cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. |
| Bortezomib and Dexamethasone (VD) | Active comparator | Drug: Bortezomib, Drug: DexamethasoneEach cycle is 21 days, after 2 cycles, patients who reached MR continued treatment for 2 cycles, 4 cycles in total. Subsequent treatment regimens after 4 cycles of induction therapy were determined by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Initial diagnosis of symptomatic multiple myeloma (according to the International Myeloma Working Group [IMWG] diagnostic criteria)
- Men and women aged ≥18 years and ≤75 years
- Multiple myeloma patients with measurable M protein should meet at least one of the following three tests: 1) Serum M protein ≥10 g/L; 2) Urinary M protein ≥200 mg/24h; 3) In the case of abnormal serum free light chain ratio, the level of affected free light chain ≥100 mg/L
- No prior treatment for multiple myeloma
- ECOG score ≤2, and predicted survival ≥3 months
Key exclusion criteria (19 listed)
- Primary renal disease or secondary renal injury not related to multiple myeloma, such as diabetes
- Prior treatment for myeloma (excluding radiation, bisphosphonates, or a single short-term hormone therapy [i.e., a 4-day dose less than or equivalent to dexamethasone 40mg/ day])
- Non-active multiple myeloma, including MGUS and smoking myeloma
- Prior malignancies requiring treatment or with evidence of recurrence in the 5 years prior to the first study [excluding basal cell carcinoma of the skin and the following carcinomas in situ: Squamous cell carcinoma, carcinoma in situ of bladder, carcinoma in situ of endometrium, carcinoma in situ of cervix/dysplasia, occasional histological discovery of prostate cancer (TNM stage T1a or T1b) or carcinoma in situ of breast]
- Patients with renal insufficiency accompanied by dialysis (excluding those who had received dialysis treatment due to renal insufficiency in the early stage but had not received anti-MM treatment and were not on dialysis at the time 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 |
|---|---|---|
| pomalidomideAlso: CC-4047Pomalidomide was administered orally at a dose of 4 mg on days 1-14 of each cycle. | Drug | Pomalidomide, Bortezomib and Dexamethasone (PVD) |
| BortezomibBortezomib was administered intravenously or subcutaneously at a dose of 1.3mg/m2 on days 1, 4, 8, 11 of each cycle. | Drug | Bortezomib and Dexamethasone (VD), Pomalidomide, Bortezomib and Dexamethasone (PVD) |
| DexamethasoneDexamethasone was administered orally at a dose of 20mg on days the same and next day of bortezomib administration. | Drug | Bortezomib and Dexamethasone (VD), Pomalidomide, Bortezomib and Dexamethasone (PVD) |
Primary outcome
≥very good partial response
Time frame: At end of cycle 4 (each cycle is 21 days)
The sum of a complete response and a very good partial response
4 secondary outcomes
MRD negative rate
Time frame: From randomization to the date of first documented evidence of PD until study completion, an average of 1.5 year
immunologic function
Time frame: At day 1±3 of cycle 2-5 (each cycle is 21 days)
renal tubular function
Time frame: At day 1±3 of cycle 2-5 (each cycle is 21 days)
safety（Number of adverse events ）
Time frame: Each cycle (each cycle is 21 days), up to 24 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 31 Jan 2023.
- Derived from this study: PubMed 42716009Xiao F, Wang L, Li F, Wang F, Zhong Y, Qu X, Chang C, Li Z, Liu Y, Dou X, Wen L, Peng N, Lu J, Hou J. Pomalidomide plus bortezomib and dexamethasone for newly diagnosed multiple myeloma with renal impairment: Randomized phase II study (POM-MM-003). Med. 2026 Sep 9:101293. doi: 10.1016/j.medj.2026.101293. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Hou, PhD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pomalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 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 31 Jan 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jian Hou, PhD (02168383144, houjian@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥very good partial response (time frame: At end of cycle 4 (each cycle is 21 days)). 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 NCT05432414, 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 31 Jan 2023.