Refractory Multiple MyelomaPhase 2NCT06138275
Elranatamab in R/R Multiple Myeloma
A Phase 2 study testing Elranatamab in people with Refractory Multiple Myeloma and Relapse Multiple Myeloma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma, Relapse Multiple Myeloma, Multiple Myeloma
- What is being tested?
- Elranatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2024to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Male or female participants age ≥ 18 years
- The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.
- Prior diagnosis of MM as defined according to IMWG criteria.
- Measurable disease of multiple myeloma as defined by at least one of the following prior to idecabtagene vicleucel infusion:
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- Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
- ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio (<0.26 or >1.65)
- Previously treated relapsed and refractory multiple myeloma following idecabtagene vicleucel as infusion as standard of care who have achieved at least a PR or better per IMWG criteria. Patients will have received idecabtagene per label including after at least 4 prior lines of therapy and relapsed after an immunomodulatory drug (IMiD), a proteasome inhibitor and an Anti-CD38 monoclonal antibody
- left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gated acquisition scan (MUGA) scan or echocardiogram (ECHO).
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥1000/microlitre (mcL). Use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing.
- Platelet count ≥25,000/mcL. Platelet transfusion support is permitted if completed at least 7 days prior to planned start of dosing.
- Hemoglobin ≥8 g/dL. Red blood cell transfusion support is permitted if completed at least 7 days prior to planned start of dosing.
- Calculated creatinine clearance ≥30 mL/min by Cockcroft-Gault equation.
- Patient has adequate hepatic function, as evidenced by each of the following:
- Serum total bilirubin <2 mg/dL; and
- Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values < 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin <3 mg/dL and normal direct bilirubin).
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
Who cannot join
- Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
- Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).
- Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
- Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
- Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
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- Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
- Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
- History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Previous treatment with an anti-BCMA (B-cell maturation antigen) bispecific antibody.
- Pregnant women are excluded from this study because elranatamab is an anti-BCMA bispecific antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.
- Known or suspected hypersensitivity to the study intervention or any of its excipients.
- Participants who are receiving any other investigational agents for this condition (if appropriate only).
- Live attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention.
- Toxicity from previous anticancer therapy must resolve to baseline levels or to grade ≤1, except for alopecia and peripheral neuropathy.
- Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Noopur Raje, MD, 617-726-0711, nraje@mgh.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Omar Nadeem, MD, 617-632-4218, nadeem_omar@dfci.harvard.edu
- Recruiting
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
About this study
Official title: A Phase 2 Study of Elranatamab as Consolidation After Idecabtagene Vicleucel in Relapsed Refractory Multiple Myeloma
This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.
Read the detailed description
This is an open label phase II study that will enroll patients with relapsed and refractory multiple myeloma after four or more lines of therapy who received idecabtagene vicleucel as standard of care.
The research involves study visits and receiving the study drug. Participants will receive the study drug, elranatamab, for up to 6 months and will be followed for as long as they remain in the study, until confirmed progressive disease (disease worsening), or until initiation of other myeloma treatment.
Elranatamab is a type of antibody (a protein produced by the body's immune system when it detects harmful substances) that works by binding to both T-cells (part of the immune system) and myeloma cells. The drug then activates T-cells to kill the myeloma cells. In this study we are researching whether multiple myeloma progresses after elranatamab administration. The U.S. Food and Drug Administration (FDA) has not approved elranatamab as a treatment for any disease.
It is expected that about 32 people will take part in this research study.
- Being tested
- Elranatamab
- Keywords
- relapsed/refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElranatamabDrug
subcutaneous (under the skin) injection
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab | Experimental | Elranatamab subcutaneous injections at pre-determined doses, administered at the following timepoints during each 28-day cycle: Cycle 1: Days 1, 4, 8, 15, and 22; Cycle 2: Days 1, 8, 15, and 22 ; Cycles 3-6: Days 1 and 15 Receives: Drug: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate or stringent CR (sCR) post consolidation therapy
Disease response will be assessed using the International Myeloma Working Group Response Criteria (IMWG)
Measured: The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.
Progression-free survival
Progression-Free Survival (PFS) is defined as the time from or registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. This will be estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Measured: The time from registration to the earlier of progression or death due to any cause, for up to 5 years. Participants alive without disease progression are censored at date of last disease evaluation
Secondary outcomes (7)
Incidence of adverse events (AEs)
Adverse events will be evaluated using CTCAE version 5
Measured: 3 years
Objective response rate (ORR)
ORR will be evaluated using the IMWG Uniform Response criteria
Measured: From start of treatment to 2 years post-treatment
Overall survival (OS)
Overall Survival (OS) is defined as the time from or registration to death due to any cause, or censored at date last known alive. Estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Measured: From start of treatment to 2 years post-treatment
Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate
MRD-positive to MRD-negative conversion rate is the proportion of MRD-positive participants that become MRD-negative. Point estimates of MRD positivity and negativity rates will be calculated along with the 2-sided 95% CIs using the Clopper-Pearson method.
Measured: 6 months
Rate of sustained MRD-negativity of ≥6 or ≥12 months
Sustained MRD negativity rate is the proportion of participants with MRD negativity sustained over at least 6 months or at least 12 months from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy. Point estimates of MRD negativity rate will be calculated along with the 2-sided 95% Confidence Interval (CIs) using the Clopper-Pearson method.
Measured: 6 years
Time to MRD-negativity
MRD negativity rate is the proportion of participants with negative MRD per IMWG sequencing criteria from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy. Point estimates of MRD negativity rate will be calculated along with the 2-sided 95% CIs using the Clopper-Pearson method.
Measured: From start of treatment to 2 years post-treatment
Duration of response (DOR)
The following description information was pulled from NIH: Duration of response is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response. This is estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
Measured: From start of treatment to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start8 Mar 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Noopur Raje, Massachusetts General Hospital
- Investigators
- Noopur Raje, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138275
- Sponsor's protocol ID
- 23-402
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Elranatamab as Consolidation After Idecabtagene Vicleucel in Relapsed Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06138275
- Acronym / sponsor ID
- 23-402
- Keywords
- relapsed/refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Nov 2023 (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 research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.
Detailed description
This is an open label phase II study that will enroll patients with relapsed and refractory multiple myeloma after four or more lines of therapy who received idecabtagene vicleucel as standard of care.
The research involves study visits and receiving the study drug. Participants will receive the study drug, elranatamab, for up to 6 months and will be followed for as long as they remain in the study, until confirmed progressive disease (disease worsening), or until initiation of other myeloma treatment.
Elranatamab is a type of antibody (a protein produced by the body's immune system when it detects harmful substances) that works by binding to both T-cells (part of the immune system) and myeloma cells. The drug then activates T-cells to kill the myeloma cells. In this study we are researching whether multiple myeloma progresses after elranatamab administration. The U.S. Food and Drug Administration (FDA) has not approved elranatamab as a treatment for any disease.
It is expected that about 32 people will take part in this research study.
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: ElranatamabElranatamab subcutaneous injections at pre-determined doses, administered at the following timepoints during each 28-day cycle: Cycle 1: Days 1, 4, 8, 15, and 22; Cycle 2: Days 1, 8, 15, and 22 ; Cycles 3-6: Days 1 and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Male or female participants age ≥ 18 years
- The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.
- Prior diagnosis of MM as defined according to IMWG criteria.
Key exclusion criteria (19 listed)
- Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
- Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).
- Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
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 |
|---|---|---|
| Elranatamabsubcutaneous (under the skin) injection | Drug | Elranatamab |
Primary outcome
Complete Response (CR) rate or stringent CR (sCR) post consolidation therapy
Time frame: The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.
Disease response will be assessed using the International Myeloma Working Group Response Criteria (IMWG)
Progression-free survival
Time frame: The time from registration to the earlier of progression or death due to any cause, for up to 5 years. Participants alive without disease progression are censored at date of last disease evaluation
Progression-Free Survival (PFS) is defined as the time from or registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. This will be estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.
7 secondary outcomes
Incidence of adverse events (AEs)
Time frame: 3 years
Objective response rate (ORR)
Time frame: From start of treatment to 2 years post-treatment
Overall survival (OS)
Time frame: From start of treatment to 2 years post-treatment
Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate
Time frame: 6 months
Rate of sustained MRD-negativity of ≥6 or ≥12 months
Time frame: 6 years
Time to MRD-negativity
Time frame: From start of treatment to 2 years post-treatment
Duration of response (DOR)
Time frame: From start of treatment to 2 years post-treatment
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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Noopur Raje, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elranatamab in people with Refractory Multiple Myeloma and Relapse Multiple Myeloma, run by Massachusetts General Hospital at 3 sites 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 20 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: looking for participants now, as of the sponsor's last update on 31 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 3 sites 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 Noopur Raje, MD (617-726-0711, nraje@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate or stringent CR (sCR) post consolidation therapy (time frame: The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.). 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 31 Aug 2026.