Multiple MyelomaPhase 2NCT06483100
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
A Phase 2 study testing Elrantamab and clonoSEQ in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Elrantamab and clonoSEQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to 30 Jun 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to understand and willingness to sign an IRB approved written informed consent document. (Legally authorized representatives may sign and give informed consent on behalf of study participants.)
- Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma. Frontline therapy in this setting is defined as treatment received prior to first relapse and may include multiple lines of therapy per the Rajkumar et al definition if treatment changes were made for either toxicity or inadequate response to initial induction.
- Received frontline treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
- Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
- MRD-positive on Day 100 landmark assessment (80 to 160 days after AHCT), defined as >1 x 10-5 myeloma cells/cell by clonoSEQ assay (Adaptive Biotechnologies, Seattle, WA) performed on bone marrow aspirate.
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- ECOG performance status ≤ 2
- All toxicities from prior treatment should have resolved to Grade ≤ 1 prior to enrollment.
- Adequate bone marrow and organ function within 28 days prior to start of treatment as defined below:
- Platelets ≥ 75 k/cumm
- Absolute neutrophil count ≥ 1.0 k/cumm
- Hemoglobin ≥ 8 g/dL without the use of growth factors or transfusion for at least 2 weeks.
- Total bilirubin ≤ 2 × upper limit of normal (ULN; ≤ 3 x ULN if documented Gilbert's syndrome)
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN
- Creatinine clearance ≥ 30 ml/min.
- The effects of elranatamab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
Who cannot join
- Inability to identify a trackable clonoSEQ ID.
- A history of other malignancy with the exception of non-melanoma skin cancers, low or very low risk prostate cancer by NCCN criteria status post definitive therapy or currently on active surveillance, and malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. Adjuvant endocrine therapy for hormone receptor-positive breast cancer is not exclusionary.
- Currently receiving any other investigational agents.
- Prior BCMA-based treatment.
- CNS involvement of disease.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in the study.
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- Uncontrolled intercurrent illness including, but not limited to, plasma cell leukemia, POEMS syndrome, systemic amyloidosis, ongoing or active infection (bacterial, fungal, or viral).
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to first dose of elranatamab.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Michael Slade, M.D., 314-454-8304, sladem@wustl.edu
Michael Slade, M.D.
About this study
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
- Conditions
- Multiple Myeloma
- Being tested
- Elrantamab, clonoSEQ
- Keywords
- Maintenance, Stem cell transplant, Immunotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElrantamabDrug
- Elranatamab will be dosed in 28-day cycles as follows:
- C1D1: 12 mg SC priming dose
- C1D3: 32 mg SC priming dose
- C1D8, C1D15, C1D22: 76 mg SC
- Cycle 2-Cycle 7: 76 mg SC on D1 and D15
- Cycle 8 and subsequent cycles: 76 mg SC on D1
clonoSEQDevice
FDA approved MRD testing
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab | Experimental | Patients will receive at least 12 months of maintenance elranatamab therapy. Patients will have MRD testing within clonoSEQ every 6 months. If 2 consecutive tests are negative, elranatamab will be stopped and the patient will go on observation schedule.
Once a patient starts the observation schedule, standard disease monitoring will be performed every 3 months and bone marrow-based MRD will be performed every 6 months until MRD recurrence, disease progression or end of study period (patients' on-study status will be a maximum of 36 months for treatment and intensive observation combined). Patients who experience MRD recurrence will be re-treated per study protocol. A patient may move back to the observation schedule after treatment re-initiation provided the same criteria as above are met (2 consecutive negative MRD tests). Patients who are determined to have progressive disease per IMWG criteria (whether on treatment or observation schedule) will transition off study. Receives: Drug: Elrantamab; Device: clonoSEQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as time to progression or death.
Measured: Through completion of follow-up (up to 5 years)
Proportion of patients achieving MRD negativity at the 10^-5 threshold per the clonoSEQ assay
Measured: Through completion of end of study visit (up to 36 months)
Secondary outcomes (9)
Event-free survival (EFS)
Composite of progression, death, or treatment intolerance (discontinuation due to toxicity)
Measured: Through completion of follow-up (up to 5 years)
Time to next therapy
Time to next therapy (TTNT) is defined as the time to initiation of subsequent anti-myeloma therapy (excluding standard-of-care maintenance).
Measured: Through completion of follow-up (up to 5 years)
Maximum depth of response by IMWG criteria
Measured: Through completion of end of study visit (up to 36 months)
Proportion of patients achieving sustained MRD-negativity at the 10^-5 threshold per the clonoSEQ assay for at least 12 months
MRD negativity per the clonoSEQ assay will be defined as less than 1 myeloma cell per 10^6 bone marrow cells evaluated (i.e. <10-6)
Measured: Through completion of end of study visit (up to 36 months)
Proportion of patients discontinuing therapy per MRD-guided protocol
Measured: Through completion of treatment (up to 36 months)
Time on treatment during study period
Measured: Through completion of treatment (up to 36 months)
Incidence and severity of treatment-related adverse events by CTCAE v5
Measured: From start of treatment through 90 days after completion of treatment (up to 39 months)
Overall survival (OS)
Overall survival (OS) is defined as time to death.
Measured: Through completion of follow-up (up to 5 years)
Proportion of patients resuming therapy per MRD-guided protocol
Measured: Through completion of treatment (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start20 Dec 2024
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael Slade, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483100
- Sponsor's protocol ID
- 202409141
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
- ClinicalTrials.gov ID
- NCT06483100
- Acronym / sponsor ID
- 202409141
- Conditions
- Multiple Myeloma
- Keywords
- Maintenance, Stem cell transplant, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Pfizer
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 3 Jul 2024 (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 evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab | Experimental | Drug: Elrantamab, Device: clonoSEQPatients will receive at least 12 months of maintenance elranatamab therapy. Patients will have MRD testing within clonoSEQ every 6 months. If 2 consecutive tests are negative, elranatamab will be stopped and the patient will go on observation schedule. Once a patient starts the observation schedule, standard disease monitoring will be performed every 3 months and bone marrow-based MRD will be performed every 6 months until MRD recurrence, disease progression or end of study period (patients' on-study status will be a maximum of 36 months for treatment and intensive observation combined). Patients who experience MRD recurrence will be re-treated per study protocol. A patient may move back to the observation schedule after treatment re-initiation provided the same criteria as above are met (2 consecutive negative MRD tests). Patients who are determined to have progressive disease per IMWG criteria (whether on treatment or observation schedule) will transition off study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age
- Ability to understand and willingness to sign an IRB approved written informed consent document. (Legally authorized representatives may sign and give informed consent on behalf of study participants.)
- Received autologous hematopoietic cell transplantation (with or without tandem transplant) as part of frontline therapy for newly diagnosed IgG or IgA multiple myeloma. Frontline therapy in this setting is defined as treatment received prior to first relapse and may include multiple lines of therapy per the Rajkumar et al definition if treatment changes were made for either toxicity or inadequate response to initial induction.
- Received frontline treatment with at least a triplet regimen including a PI and an IMID (+/- an anti-CD38 antibody)
- Disease response of ≥ partial response (PR) by IMWG criteria at time of study screening (post-transplant).
Key exclusion criteria (9 listed)
- Inability to identify a trackable clonoSEQ ID.
- A history of other malignancy with the exception of non-melanoma skin cancers, low or very low risk prostate cancer by NCCN criteria status post definitive therapy or currently on active surveillance, and malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. Adjuvant endocrine therapy for hormone receptor-positive breast cancer is not exclusionary.
- Currently receiving any other investigational agents.
- Prior BCMA-based treatment.
- CNS involvement of disease.
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 |
|---|---|---|
| Elrantamab- Elranatamab will be dosed in 28-day cycles as follows: * C1D1: 12 mg SC priming dose * C1D3: 32 mg SC priming dose * C1D8, C1D15, C1D22: 76 mg SC * Cycle 2-Cycle 7: 76 mg SC on D1 and D15 * Cycle 8 and subsequent cycles: 76 mg SC on D1 | Drug | Elranatamab |
| clonoSEQFDA approved MRD testing | Device | Elranatamab |
Primary outcome
Progression-free survival (PFS)
Time frame: Through completion of follow-up (up to 5 years)
Progression-free survival (PFS) is defined as time to progression or death.
Proportion of patients achieving MRD negativity at the 10^-5 threshold per the clonoSEQ assay
Time frame: Through completion of end of study visit (up to 36 months)
9 secondary outcomes
Event-free survival (EFS)
Time frame: Through completion of follow-up (up to 5 years)
Time to next therapy
Time frame: Through completion of follow-up (up to 5 years)
Maximum depth of response by IMWG criteria
Time frame: Through completion of end of study visit (up to 36 months)
Proportion of patients achieving sustained MRD-negativity at the 10^-5 threshold per the clonoSEQ assay for at least 12 months
Time frame: Through completion of end of study visit (up to 36 months)
Proportion of patients discontinuing therapy per MRD-guided protocol
Time frame: Through completion of treatment (up to 36 months)
Time on treatment during study period
Time frame: Through completion of treatment (up to 36 months)
Incidence and severity of treatment-related adverse events by CTCAE v5
Time frame: From start of treatment through 90 days after completion of treatment (up to 39 months)
Overall survival (OS)
Time frame: Through completion of follow-up (up to 5 years)
Proportion of patients resuming therapy per MRD-guided protocol
Time frame: Through completion of treatment (up to 36 months)
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 6 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Michael Slade, M.D. principal investigator
Washington University School of Medicine
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 Elrantamab and clonoSEQ in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
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 16 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Aug 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 United States. 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?
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 Michael Slade, M.D. (314-454-8304, sladem@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Through completion of follow-up (up to 5 years)). The study lists 2 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 6 Aug 2026.