Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a cancer drug stop myeloma before it starts?

NCT ID NCT02316106

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested three different schedules of the drug daratumumab in 123 people with smoldering multiple myeloma, a condition that often progresses to active multiple myeloma. The goal was to see how well each schedule controlled the disease and led to complete responses. Researchers measured response rates and how many patients progressed or died.

What this could mean

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

Active substance
daratumumab
What this could lead to
If successful, this could help delay or prevent smoldering multiple myeloma from becoming active multiple myeloma, potentially reducing the need for more intensive treatments.
What could go wrong
This is a phase 2 trial with only 123 participants, so results are preliminary. Daratumumab may cause side effects like infusion reactions or infections, and not all patients may 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

123 people

The number who actually took part.

Started

May 2015

Finished

Jun 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: * Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years * Have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Exclusion Criteria: * Active multiple myeloma,requiring treatment as defined by the study protocol * Primary systemic AL (immunoglobulin light chain) amyloidosis * Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with corticosteroids with a dose greater than (\>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1 * History of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix * Known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years * Any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

plasma cell myeloma Smoldering Multiple Myeloma smoldering 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

  • Study site

    Little Rock, Arkansas, United States

  • Study site

    Jacksonville, Florida, United States

  • Study site

    West Palm Beach, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Ann Arbor, Michigan, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Hackensack, New Jersey, United States

  • Study site

    New York, New York, United States

  • Study site

    Chapel Hill, North Carolina, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Columbus, Ohio, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Box Hill, Australia

  • Study site

    Concord, Australia

  • Study site

    Melbourne, Australia

  • Study site

    Woodville South, Australia

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Edmonton, Alberta, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Brno, Czechia

  • Study site

    Hradec Králové, Czechia

  • Study site

    Prague, Czechia

  • Study site

    Lille, France

  • Study site

    Nantes, France

  • Study site

    Paris, France

  • Study site

    Pierre-Bénite, France

  • Study site

    Rennes, France

  • Study site

    Berlin, Germany

  • Study site

    Chemnitz, Germany

  • Study site

    Essen, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    Mainz, Germany

  • Study site

    München, Germany

  • Study site

    Tübingen, Germany

  • Study site

    Würzburg, Germany

  • Study site

    Haifa, Israel

  • Study site

    Jerusalem, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Tel Aviv, Israel

  • Study site

    Amsterdam, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    Utrecht, Netherlands

  • Study site

    Nizhny Novgorod, Russia

  • Study site

    Petrozavodsk, Russia

  • Study site

    Ryazan, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Ankara, Turkey (Türkiye)

  • Study site

    Antalya, Turkey (Türkiye)

  • Study site

    Izmir, Turkey (Türkiye)

  • Study site

    Samsun, Turkey (Türkiye)

  • Study site

    Cardiff, United Kingdom

  • Study site

    Nottingham, United Kingdom

  • Study site

    Southampton, United Kingdom

  • Study site

    Surrey, United Kingdom

More trials for these conditions

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