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Relapsed/Refractory Multiple MyelomaPhase 4NCT07881835

A Phase IV Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma That is Not Responding to Four or More Standard Treatments or Has Come Back After Several Standard Treatments

A Phase 4 study testing Elranatamab in people with Relapsed/Refractory Multiple Myeloma and Multiple Myeloma, run by Pfizer.

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
Search all trials

Trial summary

This is a Phase 4, multicenter, open-label, single-arm study evaluating the safety and efficacy of elranatamab monotherapy in adult participants with relapsed or refractory multiple myeloma in India. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Elranatamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
22 Oct 2026to 16 Feb 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are eligible to be included in this study only if all of the following criteria apply:
  • Age and Sex:
  • 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening.
  • Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
  • Disease Characteristics:
  • Prior diagnosis of MM as defined according to IMWG criteria and currently having at least 1 of the following
Show all 56Show fewer
  • Serum M-protein ≥0.5 g/dL by SPEP
  • Urinary M-protein excretion ≥200 mg/24 hours by UPEP
  • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Previously received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
  • Other Inclusion criteria:
  • Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study treatment plan; required concomitant medications, laboratory test and are willing to participate.
  • ECOG PS 0 or 1 5.2. Exclusion Criteria
  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions:
  • Any of the conditions mentioned below:
  • Plasma cell leukemia (anytime prior study entry) , Smoldering MM (at study entry), Waldenström's macroglobulinemia (anytime prior study entry), Amyloidosis (anytime prior study entry).
  • POEMS Syndrome.
  • Known CNS involvement or clinical signs of myelomatous meningeal involvement.
  • History of stem cell transplant within 12 weeks prior to enrollment.
  • Active GVHD (other than Grade 1 skin involvement), or GVHD requiring treatment.
  • Participants with 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 of the cervix, Bowen's disease.
  • Ongoing Grade 2 or higher peripheral sensory or motor neuropathy.
  • History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • Known or suspected hypersensitivity to elranatamab or any other study interventions or any of their excipients.
  • Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Prior/Concomitant Therapy:
  • Previous treatment with an anti-BCMA bispecific antibody or a CD3-redirecting therapy.
  • Cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14-day period before the first dose of study intervention.
  • Any anti-myeloma drug therapy within 14 days of the first dose of study intervention (includes dexamethasone). Bisphosphonate use permitted.
  • Live attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention.
  • Prior/Concurrent Clinical Study Experience:
  • Previous administration with an investigational product (drug or vaccine) 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). A participant may be eligible even if they are in the follow-up phase of an investigational study if they meet the criterion for time elapsed from previous administration of investigational product. Cases must be discussed with sponsor's medical monitor to judge eligibility.
  • Diagnostic Assessments:
  • Hepatic dysfunction defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary:
  • Total bilirubin >2 × ULN (except for Gilbert's syndrome, direct bilirubin >3 × ULN is exclusionary)
  • AST >2.5 × ULN
  • ALT >2.5 × ULN
  • Hematologic abnormalities defined as any 1 of the following,:
  • ANC <1000/mm3,(use of G-CSFs is permitted if completed at least 7 days prior to eligibility sample collection and at least 7 days prior to planned start of dosing)
  • Platelet count <75,000/μL if <50% of BM nucleated cells are plasma cells, or <50,000/μL if ≥50% of BM nucleated cells are plasma cells (transfusion support is permitted if completed at least 7 days prior to eligibility sample collection and at least 7 days prior to planned start of dosing); and
  • Hemoglobin <8 g/dL (transfusion support is permitted if completed at least 14 days prior to eligibility sample collection and at least 14 days prior to planned start of dosing).
  • NOTE: Hematologic parameters are also to be met on C1D1 prior to proceeding with study treatment.
  • Active HBV, HCV, SARS-CoV-2, known HIV or AIDS, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must be completed at least 28 days prior to enrollment. Prophylactic use of systemic anti-infective agents is permitted. Participants whose HIV or HCV status cannot be determined from their medical history must be screened for HIV and HCV up to 28 days prior to enrollment.
  • COVID-19/SARS-CoV-2: SARS-CoV-2 PCR testing is mandated within 5 days prior to enrollment. Participants with positive PCR test result for SARS-CoV-2 within 5 days prior to enrollment, or suspected of having SARS-CoV-2, are excluded.
  • HIV: In equivocal cases, participants whose viral load is negative may be eligible. HIV seropositive participants who are otherwise healthy and at low risk for AIDS-related outcomes could be considered eligible. Potential eligibility for a specific HIV positive protocol candidate should be evaluated and discussed with the sponsor prior to screening, considering current and past CD4+ and T-cell counts, history (if any) of AIDS defining conditions (eg, opportunistic infections), status of HIV treatment and the potential for drug-drug interactions.
  • HBV:
  • Participants with a positive HBsAg test (ie, either acute or chronic active hepatitis) are excluded.
  • Participants with HBV antibody positivity indicating immunity, either due to vaccination or prior natural infection, are eligible.
  • Participants with positive anti-HBcAb but negative HBsAg and negative anti-HBsAb profile are eligible if HBV DNA is not detected. See Appendix 15.
  • For additional details, refer to CDC website (https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf).
  • HCV: Positive HCV antibody is indicative of infection but may not necessarily render a potential candidate ineligible, depending on clinical circumstances. If exposure to HCV is recent, HCV antibody may not have yet turned positive. In these circumstances it is recommended to test for HCV RNA. If HCV RNA is detected, the patient is not eligible. Refer to CDC website for further details (https://www.cdc.gov/hepatitis/hcv/pdfs/hcv_graph.pdf).
  • Lung imaging is required within 7 days prior to enrollment. Participants with evidence of active respiratory infection are excluded
  • Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, clinically important atrial or ventricular arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), serious conduction system abnormalities (eg, bifascicular block defined as right bundle branch and left anterior or posterior hemiblock, 3rd degree AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo-embolic disease. Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2, atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation). If a participant has a cardiac rhythm device/pacemaker placed and QTcF >470 ms, the participant may be considered eligible. Participants with cardiac rhythm device/pacemaker must be discussed in detail with the sponsor to judge eligibility.
  • Other Exclusion Criteria:
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

About this study

Official title: A PHASE-4 MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY EVALUATING ELRANATAMAB AS MONOTHERAPY IN ADULT PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA IN INDIA, WITH AT LEAST FOUR PRIOR THERAPIES, INCLUDING AN IMMUNOMODULATORY AGENT, A PROTEASOME INHIBITOR AND AN ANTI-CD38 ANTIBODY

This is a Phase 4, multicenter, open-label, single-arm study evaluating the safety and efficacy of elranatamab monotherapy in adult participants with relapsed or refractory multiple myeloma in India. Eligible participants must have received at least four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

All enrolled participants will receive elranatamab; there is no comparator or control arm. Approximately 100 participants are planned to be enrolled across approximately 10 study sites in India.

Study assessments will include evaluation of disease response and monitoring of adverse events in accordance with the study protocol.

Read the detailed description

This Phase 4, multicenter, open-label, single-arm study is being conducted in India following approval of elranatamab by the Central Drugs Standard Control Organization (CDSCO). The study is intended to fulfill a post-approval requirement and further characterize the safety and efficacy of elranatamab in Indian patients with relapsed or refractory multiple myeloma. The study plans to enroll approximately 100 participants across approximately 10 sites in India.

The study population consists of adult patients in India with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and who have demonstrated disease progression on their last therapy.

Participants who meet the eligibility criteria will enter an open-label treatment phase and receive elranatamab monotherapy. Elranatamab will be administered using a step-up dosing regimen consisting of 12 mg on Day 1 and 32 mg on Day 4, followed by a full treatment dose of 76 mg once weekly from Week 2 through Week 24. For participants who have received at least 24 weeks of treatment and achieved a response, the dosing interval will transition to once every 2 weeks. Subsequently, if the response is maintained, the dosing interval may be extended to once every 4 weeks after Cycle 13 Day 1 based on the investigator's judgment.

Study assessments will be performed according to the Schedule of Activities and will include evaluation of disease response, safety monitoring, and collection of study-specific clinical data. There is no comparator or control arm.

Following completion or discontinuation of study treatment, participants will undergo an End-of-Treatment (EOT) visit, anticipated to occur approximately 12 months after enrollment. Participants will subsequently complete a safety follow-up visit approximately 3 months after the last dose of study treatment. The study will further characterize the safety profile and clinical outcomes associated with elranatamab monotherapy in participants with relapsed or refractory multiple myeloma in India.

Being tested
Elranatamab
Keywords
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma, Elranatamab, Plasma Cell Neoplasm
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.

  • ElranatamabDrug

    Also called Elduxio

    Elranatamab is a bispecific T-cell-engaging monoclonal antibody targeting B-cell maturation antigen (BCMA) and CD3.

Study groups in NCT07881835
Study groupRoleWhat they receive
ElranatamabExperimentalParticipants with relapsed or refractory multiple myeloma who meet the eligibility criteria will receive open-label elranatamab monotherapy. Elranatamab will be administered using a step-up dosing regimen consisting of 12 mg on Day 1 and 32 mg on Day 4, followed by 76 mg once weekly from Week 2 through Week 24. For participants who have received at least 24 weeks of treatment and achieved a response, the dosing interval will transition to every 2 weeks. Subsequently, if the response is maintained, the dosing interval may be extended to every 4 weeks after Cycle 13 Day 1 based on investigator judgment.
Receives: Drug: Elranatamab

What is being measured

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

  1. Adverse Events (AEs)

    Number, frequency and severity of treatment-emergent adverse events (TEAEs), graded according to NCI CTCAE Version 5.0.

    Measured: From first dose of elranatamab through the End-of-Treatment visit -approximately 12 months after enrollment)

  2. Laboratory Abnormalities

    Laboratory abnormalities characterized by type, frequency, severity (graded according to NCI CTCAE Version 5.0), and timing.

    Measured: From first dose of elranatamab through the End-of-Treatment visit -approximately 12 months after enrollment)

Secondary outcomes (4)

  1. Progression-Free Survival (PFS) Rate at 12 Months

    Proportion of participants alive without disease progression 12 months after first dose.

    Measured: 12 months

  2. Overall Survival (OS) Rate at 12 Months

    Proportion of participants alive at 12 months after first dose of study treatment.

    Measured: 12 months

  3. Overall Response Rate (ORR)

    Proportion of participants achieving an objective response as assessed by the investigator according to IMWG response criteria.

    Measured: up to 12 months

  4. Complete Response Rate (CRR)

    Proportion of participants achieving complete response (CR) or better according to IMWG response criteria.

    Measured: Up to 12 months

Timeline

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

  1. First posted19 Oct 2026
  2. Study start22 Oct 2026 (estimated)
  3. Primary completion16 Feb 2029 (estimated)
  4. Study completion16 Feb 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
Not applicable
Intervention model
Single group
Model description
All enrolled participants who meet the eligibility criteria will receive open-label elranatamab monotherapy. Elranatamab will be administered using a step-up dosing regimen of 12 mg on Day 1 and 32 mg on Day 4, followed by 76 mg once weekly from Week 2 through Week 24. Participants achieving a response after at least 24 weeks of treatment may transition to every-2-week dosing, and subsequently to every-4-week dosing after Cycle 13 Day 1, based on investigator judgment and sustained response. There is no comparator or control arm.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07881835
Sponsor's protocol ID
C1071053
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Elranatamab in people with Relapsed/Refractory Multiple Myeloma and Multiple Myeloma, run by Pfizer.

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 56 inclusion and 0 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 19 Oct 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 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 Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: From first dose of elranatamab through the End-of-Treatment visit -approximately 12 months after enrollment)). 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?

On the ClinicalTrials.gov record for NCT07881835.

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 19 Oct 2026.

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