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Multiple MyelomaPhase 4NCT07334535

Isa-VRD in TIE HRMM

A Phase 4 study testing Isatuximab, bortezomib, lenalidomide, dexamethason and Bortezomib, Lenalidomide, Dexamethasone in people with Multiple Myeloma, run by Peking Union Medical College Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, prospective, randomized controlled trial designed to compare the quadruplet regimen of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRD) with the standard triplet regimen (VRD) in newly diagnosed, transplant-ineligible patients with high-risk multiple myeloma (HRMM). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Isatuximab, bortezomib, lenalidomide, dexamethason and Bortezomib, Lenalidomide, Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteChina
Study dates
30 Jan 2026to Jan 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed Multiple myeloma ，meeting the IMWG 2025 definition of high-risk MM (any one criterion):
  • Del(17p) (>20% of plasma cells) and/orTP53 mutation or（2）One of these translocations cooccurring with 1q+ and/or del(1p32) , or t(4;14), or t(14;16), or t(14;20) or （3） Monoallelic del(1p32) along with 1q+ or biallelic del(1p32) or（4） High β2M (>5.5 mg/dL) with normal creatinine (<1.2 mg/dL) or（5）Or presents with any other high-risk feature: meeting diagnostic criteria for primary plasma cell leukemia or presence of extramedullary plasmacytoma at baseline;
  • Age ≥18 years and ≤80 years;
  • Not eligible for autologous hematopoietic stem cell transplantation or has declined transplantation for other reasons.
  • ECOG score 0-2
  • Expected survival time > 3 months
Show all 9Show fewer
  • Sufficient organ function is defined as follows: absolute neutrophil count ≥ 1.0×10^9/L, platelet count ≥ 50×10^9/L (when the proportion of bone marrow plasma cells is <50%), hemoglobin ≥ 7.5 g/dL; total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance rate ≥ 30 mL/min; left ventricular ejection fraction ≥ 50%.
  • Fertile female or male subjects must agree to take effective contraceptive measures during the study period and within the specified time after the last administration.
  • Voluntarily participated in this study, signed the informed consent form, had good compliance, and was cooperative during the follow-up.

Who cannot join

  • Prior systemic anti-myeloma therapy;
  • Viral infections including HBV, HCV, HIV, etc.;
  • Serious cardiovascular and cerebrovascular diseases, such as: within 6 months before screening, myocardial infarction, unstable angina pectoris, severe arrhythmia, New York Heart Function Classification III-IV grade, or left ventricular ejection fraction <50%.
  • Severe neurological or mental disorders that affect the ability to give informed consent or comply with the protocol.
  • Had an allergic reaction to isatuximab, bortezomib, lenalidomide, dexamethasone or any excipients
  • Pregnant or lactating women.
  • Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study.
  • The researcher believes that there are any other circumstances unsuitable for participating in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhuang Junling, PhD.MD contact

+86 13910118511

zhuangjunling@pumch.cn

Fujing Zhang, MD. contact

+86 15701569090

China1 site

  • Junling Zhuang

    Beijing, Beijing Municipality, 100730

    Junling Zhuang, +8613910118511, zhuangjunling@pumch.cn

Other trials in China

About this study

Official title: A Prospective, Randomized, Multi-center Study Comparing Isatuximab in Combination With VRD Versus VRD in High-Risk, Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma.

This is a multicenter, prospective, randomized controlled trial designed to compare the quadruplet regimen of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRD) with the standard triplet regimen (VRD) in newly diagnosed, transplant-ineligible patients with high-risk multiple myeloma (HRMM).

Primary Hypothesis:

Read more

The addition of isatuximab to VRD will significantly improve the MRD negativity rate at 12 months compared to VRD alone in HR-NDMM patients.

Secondary Hypotheses:

Isa-VRD will lead to higher overall response rates (ORR), deeper responses, and improved progression-free survival (PFS) and overall survival (OS).

The safety profile of Isa-VRD will be manageable and consistent with the known safety profiles of its individual components.

Read the detailed description

This is a prospective, multicenter, randomized, open-label, Phase IIIb clinical trial. The study aims to evaluate the efficacy and safety of the quadruplet regimen Isatuximab in combination with Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRD) compared to the standard triplet regimen of Bortezomib, Lenalidomide, and Dexamethasone (VRD) in newly diagnosed high-risk multiple myeloma (HRMM) patients who are not candidates for autologous stem cell transplantation.

A total of 117 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either Isa-VRD (78 participants) or VRD (39 participants). The study consists of an induction-consolidation phase (cycles 1-12) followed by a maintenance phase (from cycle 13 onwards until disease progression or unacceptable toxicity).

The primary endpoint is the rate of minimal residual disease (MRD) negativity in the bone marrow assessed by flow cytometry at 12 months of treatment. Key secondary endpoints include MRD negativity rate at 18 months, objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety profile.

Being tested
Isatuximab, bortezomib, lenalidomide, dexamethason, Bortezomib, Lenalidomide, Dexamethasone
Keywords
multiple myeloma, isatuximab, RCT
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Isatuximab, bortezomib, lenalidomide, dexamethasonDrug

    Participants in this group will receive the quadruplet induction-consolidation regimen of Isatuximab in combination with Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Isatuximab, Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.

  • Bortezomib, Lenalidomide, DexamethasoneDrug

    Participants in this group will receive the standard triplet induction-consolidation regimen of Bortezomib, Lenalidomide, and Dexamethasone (VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.

Study groups in NCT07334535
Study groupRoleWhat they receive
IsaVRD groupExperimentalParticipants in this group will receive the quadruplet induction-consolidation regimen of Isatuximab in combination with Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Isatuximab, Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.
Receives: Drug: Isatuximab, bortezomib, lenalidomide, dexamethason
VRD groupActive comparatorParticipants in this group will receive the standard triplet induction-consolidation regimen of Bortezomib, Lenalidomide, and Dexamethasone (VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.
Receives: Drug: Bortezomib, Lenalidomide, Dexamethasone

What is being measured

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

  1. MRD negativity rate at 12 months

    MRD negativity rate at 12 months post-treatment initiation, assessed by EuroFlow (NGF) with a sensitivity of at least 10-5

    Measured: at 12 months post-treatment initiation

Secondary outcomes (4)

  1. MRD negativity rate at 18 months

    MRD negativity rate at 18 months post-treatment initiation, assessed by EuroFlow (NGF) with a sensitivity of at least 10-5

    Measured: at 18 months post-treatment initiation

  2. Progression-free survival

    from enrollment to first disease progression

    Measured: From date of enrollment until the date of first documented progression

  3. overall survival

    from enrollment to death with follow-up

    Measured: : From date of enrollment until the date of death from any cause

  4. Overall response rate

    The proportion of participants who achieve a predefined response or better according to the International Myeloma Working Group (IMWG) uniform response criteria. The response categories included in the ORR calculation are: stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR). ORR will be calculated as (number of participants with sCR+CR+VGPR+PR) / (total number of response-evaluable participants) * 100%.

    Measured: From randomization until the end of the induction-consolidation phase

Timeline

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

  1. First posted12 Jan 2026
  2. Study start30 Jan 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334535
Sponsor's protocol ID
K9520
Other IDs
2025-PUMCH-C-040
Status last verified
Jan 2026
First submitted
3 Jan 2026
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: individual baseline characteristic, treatment and follow-up results will be shared after publication

Publications

  • Davies FE, Pawlyn C, Usmani SZ, San-Miguel JF, Einsele H, Boyle EM, Corre J, Auclair D, Cho HJ, Lonial S, Sonneveld P, Stewart AK, Bergsagel PL, Kaiser MF, Weisel K, Keats JJ, Mikhael JR, Morgan KE, Ghobrial IM, Orlowski RZ, Landgren CO, Gay F, Caers J, Chng WJ, Chari A, Walker BA, Kumar SK, Costa LJ, Anderson KC, Morgan GJ. Perspectives on the Risk-Stratified Treatment of Multiple Myeloma. Blood Cancer Discov. 2022 Jul 6;3(4):273-284. doi: 10.1158/2643-3230.BCD-21-0205.

    PubMed 35653112

  • Facon T, Dimopoulos MA, Leleu XP, Beksac M, Pour L, Hajek R, Liu Z, Minarik J, Moreau P, Romejko-Jarosinska J, Spicka I, Vorobyev VI, Besemer B, Ishida T, Janowski W, Kalayoglu-Besisik S, Parmar G, Robak P, Zamagni E, Goldschmidt H, Martin TG, Manier S, Mohty M, Oprea C, Bregeault MF, Mace S, Berthou C, Bregman D, Klippel Z, Orlowski RZ; IMROZ Study Group. Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Oct 31;391(17):1597-1609. doi: 10.1056/NEJMoa2400712. Epub 2024 Jun 3.

    PubMed 38832972

  • Leleu X, Hulin C, Lambert J, Bobin A, Perrot A, Karlin L, Roussel M, Montes L, Cherel B, Chalopin T, Slama B, Chretien ML, Laribi K, Dingremont C, Roul C, Mariette C, Rigaudeau S, Calmettes C, Dib M, Tiab M, Vincent L, Delaunay J, Santagostino A, Macro M, Bourgeois E, Orsini-Piocelle F, Gay J, Bareau B, Bigot N, Vergez F, Lebreton P, Tabrizi R, Waultier-Rascalou A, Frenzel L, Le Calloch R, Chalayer E, Braun T, Lachenal F, Corm S, Kennel C, Belkhir R, Blade JS, Joly B, Richez-Olivier V, Gardeney H, Demarquette H, Robu-Cretu D, Garderet L, Newinger-Porte M, Kasmi A, Royer B, Decaux O, Arnulf B, Belhadj K, Touzeau C, Mohty M, Manier S, Moreau P, Avet-Loiseau H, Corre J, Facon T. Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial. Nat Med. 2024 Aug;30(8):2235-2241. doi: 10.1038/s41591-024-03050-2. Epub 2024 Jun 3.

    PubMed 38830994

  • Deckert J, Wetzel MC, Bartle LM, Skaletskaya A, Goldmacher VS, Vallee F, Zhou-Liu Q, Ferrari P, Pouzieux S, Lahoute C, Dumontet C, Plesa A, Chiron M, Lejeune P, Chittenden T, Park PU, Blanc V. SAR650984, a novel humanized CD38-targeting antibody, demonstrates potent antitumor activity in models of multiple myeloma and other CD38+ hematologic malignancies. Clin Cancer Res. 2014 Sep 1;20(17):4574-83. doi: 10.1158/1078-0432.CCR-14-0695. Epub 2014 Jul 1.

    PubMed 24987056

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Isatuximab, bortezomib, lenalidomide, dexamethason and Bortezomib, Lenalidomide, 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 9 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhuang Junling, PhD.MD (+86 13910118511, zhuangjunling@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity rate at 12 months (time frame: at 12 months post-treatment initiation). 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 NCT07334535, which also lists 4 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 13 Jan 2026.

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Isa-VRD in TIE HRMM (NCT07334535) | AzTrials