Myeloma MultiplePhase 1/2CONQUISTADORNCT07600151
Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma
A Phase 1/2 study testing Etentamig, Isatuximab and Bortezomib + Lenalidomide + Dexamethasone in people with Myeloma Multiple and Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma Multiple, Myeloma
- What is being tested?
- Etentamig, Isatuximab and Bortezomib + Lenalidomide + Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2026to 31 Dec 2036
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must have High-risk myeloma according to IMS/IMWG CGS
- Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
- Participants must have clinical laboratory values within a prespecified range.
Who cannot join
- Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
- known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
- Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
- known central nervous system involvement by MM.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg
Katja Weisel, +4940-7410-0, k.weisel@uke.de
About this study
Official title: A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients
This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.
- Conditions
- Myeloma Multiple, Myeloma
- Being tested
- Etentamig, Isatuximab, Bortezomib + Lenalidomide + Dexamethasone
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtentamigDrug
Administered per the protocol
IsatuximabDrug
Administered per the protocol
Bortezomib + Lenalidomide + DexamethasoneDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 (Phase I) | Experimental | First dose level of etentamig to be explored in combination with Isa-VRd Receives: Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone |
| Dose Level 2 (Phase I) | Experimental | Second dose level of etentamig to be explored in combination with Isa-VRd Receives: Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone |
| RP2D in Phase II | Experimental | RP2D of etentamig to be explored in combination with Isa-VRd Receives: Drug: Etentamig; Drug: Isatuximab; Drug: Bortezomib + Lenalidomide + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (Phase I)
Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants
Measured: through induction treatment, on average 4 months
MRD negativity (Phase II)
MRD-negativity rate after 12 cycles (with a sensitivity of <10-5)
Measured: through consolidation phase completion, an average of 1 year
PFS
Progression-free survival
Measured: up to 10 years
Secondary outcomes (11)
ORR
Overall response rate
Measured: up to 10 years
CR rate
Complete Response Rate
Measured: up to 10 years
VGPR Rate
Very good partial response rate
Measured: up to 10 years
DoR
Duration of Response
Measured: up to 10 years
TTR
Time to response
Measured: up to 10 years
PFS2
Progression free survival 2
Measured: up to 10 years
OS
Overall survival
Measured: up to 10 years
MRD negativity
Minimal Residual Disease (MRD) Negativity Rate (10-5 to 10-6)
Measured: up to 10 years
Sustained MRD
Sustained MRD negativity rate (for a duration of 6-months, and multiples therof)
Measured: up to 10 years
MRD-negative CR
Rates of MRD-negative Complete Responses
Measured: up to 10 years
Sustained MRD-negative CR
Rate of Sustained MRD-negative Complete Response
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600151
- Sponsor's protocol ID
- CONQUISTADOR trial
- Other IDs
- 2025-523049-83-00, 2025
- Acronym
- CONQUISTADOR
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT07600151
- Acronym / sponsor ID
- CONQUISTADOR / CONQUISTADOR trial
- Conditions
- Myeloma Multiple, Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- AbbVie, Sanofi
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 20 May 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 study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 (Phase I) | Experimental | Drug: Etentamig, Drug: Isatuximab, Drug: Bortezomib + Lenalidomide + DexamethasoneFirst dose level of etentamig to be explored in combination with Isa-VRd |
| Dose Level 2 (Phase I) | Experimental | Drug: Etentamig, Drug: Isatuximab, Drug: Bortezomib + Lenalidomide + DexamethasoneSecond dose level of etentamig to be explored in combination with Isa-VRd |
| RP2D in Phase II | Experimental | Drug: Etentamig, Drug: Isatuximab, Drug: Bortezomib + Lenalidomide + DexamethasoneRP2D of etentamig to be explored in combination with Isa-VRd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must have High-risk myeloma according to IMS/IMWG CGS
- Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
- Participants must have clinical laboratory values within a prespecified range.
Key exclusion criteria (4 listed)
- Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
- known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
- Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
- known central nervous system involvement by MM.
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 |
|---|---|---|
| EtentamigAdministered per the protocol | Drug | Dose Level 2 (Phase I), Dose level 1 (Phase I), RP2D in Phase II |
| IsatuximabAdministered per the protocol | Drug | Dose Level 2 (Phase I), Dose level 1 (Phase I), RP2D in Phase II |
| Bortezomib + Lenalidomide + DexamethasoneAdministered per the protocol | Drug | Dose Level 2 (Phase I), Dose level 1 (Phase I), RP2D in Phase II |
Primary outcome
Safety and tolerability (Phase I)
Time frame: through induction treatment, on average 4 months
Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants
MRD negativity (Phase II)
Time frame: through consolidation phase completion, an average of 1 year
MRD-negativity rate after 12 cycles (with a sensitivity of <10-5)
PFS
Time frame: up to 10 years
Progression-free survival
11 secondary outcomes
ORR
Time frame: up to 10 years
CR rate
Time frame: up to 10 years
VGPR Rate
Time frame: up to 10 years
DoR
Time frame: up to 10 years
TTR
Time frame: up to 10 years
PFS2
Time frame: up to 10 years
OS
Time frame: up to 10 years
MRD negativity
Time frame: up to 10 years
Sustained MRD
Time frame: up to 10 years
MRD-negative CR
Time frame: up to 10 years
Sustained MRD-negative CR
Time frame: up to 10 years
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Etentamig, Isatuximab and Bortezomib + Lenalidomide + Dexamethasone in people with Myeloma Multiple and Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 5 inclusion and 4 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 20 May 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Katja Weisel (+4940-7410-0, k.weisel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (Phase I) (time frame: through induction treatment, on average 4 months). The study lists 3 primary outcomes in all. 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 20 May 2026.