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Multiple MyelomaPhase 2NCT06711705

Elranatamab in Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Elranatamab in people with Multiple Myeloma, run by University of California, San Diego at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment. 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?
Elranatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
18 Dec 2024to Dec 2030
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

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Prior diagnosis of relapsed/refractory MM and have received 1 to 3 prior lines of therapy as defined by the IMWG criteria (Rajkumar et al., 2014) including anti-CD38 monoclonal antibody, proteosome inhibitor (PI), and immunomodulatory drug (IMiD), and BCMA-directed chimeric antigen receptor T-cell (CAR T-cell) therapy
  • Refractory is defined as having disease progression while on therapy or within 60 days of last dose in any line, regardless of response.
  • If participant has not received BCMA-directed CAR T-cell therapy, must be ineligible for CAR T-cell therapy or deferred such treatment by participant
  • Aged greater or equal to 18 years
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  • Measurable disease as defined by any of the following:
  • Serum M-protein level ≥ 0.5 g/dL by serum protein electrophoresis (SPEP), or
  • Urine M-protein ≥ 200mg/24 hours by urine protein electrophoresis (UPEP), or
  • Involved serum free light chain ≥ 10 mg/dL (≥100mg/L) AND an abnormal serum free light chain ratio in patients without measurable disease in the serum or urine
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Adequate hematological function defined as
  • Absolute neutrophil count (ANC) ≥1,000/mm3 (G-CSF not permitted for at least 1 week prior to the first dose of elranatamab)
  • Hemoglobin ≥8.0 g/dL (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
  • Platelet count ≥75,000/mm3 or ≥50,000/mm3 if >50% involvement with plasma cells in the screening bone marrow (transfusion support is permitted if completed at least 1 week prior to planned start of dosing)
  • Adequate renal function with estimated creatinine clearance (CrCl) ≥30 mL/min as calculated using Cockcroft-Gault equation.
  • Adequate liver function defined as
  • Aspartate and alanine aminotransferase (AST and ALT) ≤2.5 x upper limit of normal (ULN); ≤5.0 x ULN if there is liver involvement by the tumor.
  • Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).
  • Total bilirubin ≤2.0 mg/dL, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3.0 mg/dL.
  • Able to receive outpatient treatment of elranatamab by meeting the following criteria:
  • Lives within 30minutes from the site of medication administration
  • Reliable caregiver present, who is able to watch participant continuously for at least until 48 hours after administration of first full treatment dose
  • No history of grade 3-4 CRS or grade 3-4 ICANS from other immune effector cell or bispecific antibody therapies
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
  • Serum pregnancy test (for females of childbearing potential) negative at screening.
  • Female patients of non-childbearing potential must meet at least 1 of the following criteria: i. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy. iii. Have medically confirmed ovarian failure. b. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
  • Agreement to adhere to Lifestyle Considerations (see section 5.3 and Appendix 2) throughout study duration

Who cannot join

  • Subjects with smoldering multiple myeloma, IgM multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome, and primary and secondary plasma cell leukemia, defined as circulating plasma cells ≥ 5%
  • Extramedullary relapse who does not meet criteria for measurable disease as above
  • Active malignancy other than Multiple Myeloma requiring treatment in the past 3 years, with the exception of successfully treated non-metastatic squamous or basal skin carcinoma
  • Known CNS involvement by multiple myeloma
  • Active, uncontrolled autoimmune disorders
  • Active uncontrolled infection. Active infections must be resolved and/or controlled at least 14 days prior to enrollment.
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  • Radiation therapy within 2 weeks prior to study entry (bone lesions requiring radiation may be treated with limited [ie, ≤25% of bone marrow in field] radiation therapy during this period).
  • Last systemic treatment within 2 weeks or 5 half lives, whichever is shorter. Subjects can receive a maximum of 160mg of dexamethasone or equivalent during screening, but at least 7 days prior to start of therapy.
  • Last radiation treatment to multiple sites within 2 weeks and single site within 1 week
  • History of autologous stem cell transplant within 100 days prior to study enrollment.
  • History of allogeneic transplant within 1 year prior to study enrollment or active graft versus host disease.
  • On immunosuppressive therapy for concurrent comorbid conditions
  • Other major uncontrolled medical comorbidities that may put patients at risk of serious adverse event with treatment with study medication.
  • Clinically significant, uncontrolled cardiac disease
  • Grade ≥2 peripheral sensory or motor neuropathy
  • History of Guillan-Barre syndrome
  • Other surgical (including major surgery within 14 days prior to enrollment) 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).
  • Pregnancy or lactation
  • Known or suspected hypersensitivity to the study intervention or any of its excipients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ah-Reum Jeong contact

(858) 822-6600

ajeong@health.ucsd.edu

Bone Marrow Transplant Research Team contact

(858) 822-5354

CancerCTO@health.ucsd.edu

United States1 site, 1 recruiting

  • University of California San Diego

    La Jolla, California, 92037

    Ah-Reum Jeong, MD, (858) 822-5354, CancerCTO@health.ucsd.edu

    Ah-Reum Jeong, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase II MRD-Adapted Study of Elranatamab in Relapsed/Refractory

This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment.

Read the detailed description

Phase II study of elranatamab in patients with relapsed/refractory multiple myeloma who has received 1 to 3 prior lines of therapy. Patients may enter treatment-free observation period if they have a sustained MRD negative response for greater than 12 months.

Being tested
Elranatamab
Keywords
Multiple Myeloma, 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.

  • ElranatamabDrug

    Also called Elrexfio

    Subcutaneous injection of elranatamab. If patient achieves MRD negative remission, patient would enter treatment-free observation period with MRD monitoring.

Study groups in NCT06711705
Study groupRoleWhat they receive
ElranatamabExperimentalTreatment with elranatamab
Receives: Drug: Elranatamab

What is being measured

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

  1. MRD negativity rate as best response

    MRD negativity rate as best response

    Measured: 1 year of starting treatment

Secondary outcomes (7)

  1. Sustained MRD negativity rate at 10^-5

    Sustained MRD negativity rate at 10^-5

    Measured: Through study completion, up to 5 years

  2. Overall response rate

    Overall response rate

    Measured: Within 1 year of treatment

  3. Complete response rate

    Complete response rate

    Measured: Within 1 year of treatment

  4. Progression free survival

    Progression free survival

    Measured: Through study completion, up to 5 years

  5. Duration of response

    Duration of response

    Measured: Through study completion, up to 5 years

  6. Safety (cytokine release syndrome, neurotoxicity, treatment-related adverse events)

    Number of participants with cytokine release syndrome, neurotoxicity, treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Through study completion, on average 4 weeks (cytokine release syndrome, neurotoxicity); Through study completion, up to 5 years (treatment-related adverse events as assessed by CTCAE v5.0 )

  7. Quality of life (questionnaire and by EORTC QLQ-MY20 questionnaire)

    Quality of life assessed by cancer therapy satisfaction questionnaire and by EORTC QLQ-MY20 questionnaire

    Measured: Through study completion, up to 5 years

Timeline

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

  1. First posted2 Dec 2024
  2. Study start18 Dec 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase II, single arm, open label clinical trial
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711705
Sponsor's protocol ID
810312
Status last verified
Feb 2026
First submitted
12 Nov 2024
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elranatamab in people with Multiple Myeloma, run by University of California, San Diego 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 29 inclusion and 20 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 20 Feb 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 Ah-Reum Jeong ((858) 822-6600, ajeong@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity rate as best response (time frame: 1 year of starting treatment). 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 NCT06711705.

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 Feb 2026.

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