Can a Four-Drug combo tame Ultra-High-Risk myeloma?

NCT ID NCT07789522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding elranatamab to a standard three-drug regimen can improve outcomes for people newly diagnosed with ultra-high-risk multiple myeloma. Researchers will give 15 participants elranatamab, isatuximab, bortezomib, and lenalidomide, and measure how many achieve minimal residual disease negativity, meaning no cancer cells are detectable. The study also tracks side effects, response rates, and how long any remission lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elranatamab (an anti-BCMA/CD3 bispecific antibody) given as a subcutaneous injection, combined with isatuximab, bortezomib, and lenalidomide
What this could lead to
If it works, this combination could offer a more effective first-line treatment for ultra-high-risk multiple myeloma, potentially improving remission rates and delaying relapse.
What could go wrong
This is a small, early-phase study with only 15 participants, so results may not apply broadly. The drug combination may cause side effects, and the trial does not guarantee a cure or long-term benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The subject voluntarily signs the informed consent form (ICF). 2. Aged 18-70 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria, with measurable disease meeting at least one of the following criteria: 1. Serum M-protein ≥1.0 g/dL 2. Urine M-protein ≥200 mg/24 hours 3. Serum involved free light chain ≥10 mg/dL with an abnormal serum free light-chain ratio 4.High-risk multiple myeloma according to the Consensus Genomic Staging (CGS) system published by the International Myeloma Society-International Myeloma Working Group (IMS-IMWG), or peripheral blood plasma cells ≥2%, or an extramedullary soft-tissue mass (EME). High-risk CGS is defined by at least one of the following criteria: (1)del(17p) with a clonal fraction \>20% and/or a TP53 mutation (2)An IGH translocation \[t(4;14), t(14;16), or t(14;20)\] combined with 1q+ or del(1p32) (3)del(1p32), defined as monoallelic deletion combined with 1q+ or biallelic deletion (5)β2-microglobulin ≥5.5 mg/L with a normal serum creatinine level Exclusion Criteria: 1. Concurrent plasma cell leukemia, central nervous system involvement, or amyloidosis. 2. Peripheral neuropathy of Grade \>1, or Grade 1 peripheral neuropathy with pain. Prior or ongoing systemic therapy or stem cell transplantation for symptomatic multiple myeloma, except for the emergency use of a short course of corticosteroids equivalent to dexamethasone 40 mg/day for 4 days, provided that the course is completed within 14 days before randomization. 3. Any contraindication to, or a history of life-threatening allergy, hypersensitivity, or intolerance to, any study drug or its excipients. 4. Pregnant or breastfeeding, or planning to become pregnant during participation in the study or within 6 months after the last dose of any study treatment. 5. Planning to father a child during participation in the study or within 100 days after the last dose of any component of the study treatment regimen.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma (MM) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.