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Promising combo tackles relapsed myeloma in early trial

NCT ID NCT01615029

Disease control Sponsor: Janssen Research & Development, LLC 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called daratumumab, given together with two standard treatments (lenalidomide and dexamethasone), in 45 people whose multiple myeloma had returned or stopped responding to prior therapy. The main goal was to check safety and see how many patients responded to the combination. The trial was completed and helped determine the best dose for future studies.

What this could mean

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

Active substance
daratumumab (a targeted antibody) combined with lenalidomide and dexamethasone
What this could lead to
If successful, this combination could offer a new treatment option for people with multiple myeloma that has returned or stopped responding to prior therapies.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply to all patients. Side effects from the drug combination could be significant, and the treatment is not a cure.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

45 people

The number who actually took part.

Started

Jun 2012

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * (Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex) * (Part 2) Have received at least 1 prior line of therapy for multiple myeloma * Be older than or be 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status (0-2) * Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed Exclusion Criteria: * Have previously received an allogenic stem cell transplant * Have received autologous stem cell transplant within 12 weeks before the first infusion * Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion * Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Copenhagen Ø, Denmark

  • Study site

    Vejle, Denmark

  • Study site

    Lille, France

  • Study site

    Nantes, France

  • Study site

    Vandœuvre-lès-Nancy, France

  • Study site

    Utrecht, Netherlands

  • Study site

    London, United Kingdom

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