Multiple Myeloma (MM)Phase 2HRMM-001NCT07789522
Safety and Efficacy of Elranatamab Plus Isatuximab, Bortezomib, and Lenalidomide in Ultra-High-Risk Multiple Myeloma
A Phase 2 study testing anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- anti-BCMA/CD3 bispecific antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Oct 2028
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily signs the informed consent form (ICF).
- Aged 18-70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria:
- Serum M-protein ≥1.0 g/dL
- Urine M-protein ≥200 mg/24 hours
- Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria:
- （1）del(17p) with a clonal fraction >20% and/or a TP53 mutation （2）An IGH translocation [t(4;14), t(14;16), or t(14;20)] combined with 1q+ or del(1p32) （3）del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion （5）β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level
Who cannot join
- Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.
- Peripheral neuropathy of Grade >1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization.
- Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.
- Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.
- Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of Elranatamab in Combination With Isatuximab, Bortezomib, and Lenalidomide in Patients With Ultra-High-Risk Multiple Myeloma.
This is a prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- anti-BCMA/CD3 bispecific antibody
- Keywords
- BCMA/CD3 bispecific antibody, Elranatamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-BCMA/CD3 bispecific antibodyDrug
Anti-BCMA/CD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC).
| Study group | Role | What they receive |
|---|---|---|
| BsAbs-treatment group | Experimental | Not described Receives: Drug: anti-BCMA/CD3 bispecific antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) negativity rate
Measured: 9 months
Secondary outcomes (6)
Adverse events and serious adverse events
Measured: Up to 2 year
Sustained MRD negativity rate
Measured: Up to 2 year
Overall response rate (ORR)
Measured: Up to 2 year
Complete response rate (CR)
Measured: Up to 2 year
Progression-free survival (PFS)
Measured: Up to 2 year
Duration of response (DoR)
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion9 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789522
- Sponsor's protocol ID
- IIT2026074
- Acronym
- HRMM-001
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of Elranatamab in Combination With Isatuximab, Bortezomib, and Lenalidomide in Patients With Ultra-High-Risk Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT07789522
- Acronym / sponsor ID
- HRMM-001 / IIT2026074
- Conditions
- Multiple Myeloma (MM)
- Keywords
- BCMA/CD3 bispecific antibody, Elranatamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 9 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 27 Aug 2026 (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 prospective, single-arm, single-center interventional study designed to evaluate the safety and efficacy of Elra-Isa-VR in patients with newly diagnosed ultra-high-risk multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BsAbs-treatment group | Experimental | Drug: anti-BCMA/CD3 bispecific antibody |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject voluntarily signs the informed consent form (ICF).
- Aged 18-70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria:
- Serum M-protein ≥1.0 g/dL
Key exclusion criteria (5 listed)
- Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis.
- Peripheral neuropathy of Grade >1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization.
- Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients.
- Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment.
- Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.
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 |
|---|---|---|
| anti-BCMA/CD3 bispecific antibodyAnti-BCMA/CD3 bispecific antibody (Elranatamab) will be administered via a subcutaneous injection (SC). | Drug | BsAbs-treatment group |
Primary outcome
Minimal residual disease (MRD) negativity rate
Time frame: 9 months
6 secondary outcomes
Adverse events and serious adverse events
Time frame: Up to 2 year
Sustained MRD negativity rate
Time frame: Up to 2 year
Overall response rate (ORR)
Time frame: Up to 2 year
Complete response rate (CR)
Time frame: Up to 2 year
Progression-free survival (PFS)
Time frame: Up to 2 year
Duration of response (DoR)
Time frame: Up to 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-BCMA/CD3 bispecific antibody in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, 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 8 inclusion and 5 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Gang An (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal residual disease (MRD) negativity rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.