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Can myeloma treatment work without steroids?

NCT ID NCT04635189

Disease control Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether daratumumab and lenalidomide can treat newly diagnosed multiple myeloma without adding steroids. The trial enrolls patients who are not candidates for high-dose chemotherapy and have not received prior treatment. The goal is to see how often infusion reactions occur and how many patients need steroids added back to their regimen.

What this could mean

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

Active substance
daratumumab combined with lenalidomide, given without steroids
What this could lead to
If successful, this approach could offer a treatment option that avoids the side effects of steroids for people with multiple myeloma who cannot undergo a transplant.
What could go wrong
This is a small phase II trial with only 28 participants, so results may not apply broadly. Removing steroids could lead to more infusion reactions or weaker responses, requiring steroids to be added back.

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 28 people

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

Started

Jul 2021

Expected to finish

Sep 2027

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 75 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: * Diagnosis of multiple myeloma with diagnosis * Must not have received previous therapy for multiple myeloma * Newly diagnosed and not considered candidate for high-dose chemotherapy * Adequate organ system function * A performance status ≤ 3 * Ability to swallow and retain oral medication * Female subjects of child bearing potential must be surgically sterile, be post-menopausal Exclusion Criteria: * A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma * A diagnosis of Waldenström's disease * Receiving cancer therapy * Radiation therapy within 14 days of enrollment * Major surgery within 2 weeks before enrollment * Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months * Seropositive for hepatitis B, or seropositive for hepatitis C * Ongoing systemic bacterial, fungal or viral infection * Severe and/or uncontrolled medical conditions * Malignancy within 2 years of study enrollment * Women who are pregnant or lactating * Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

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