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New drug cocktail shows promise in slowing blood cancer progression

NCT ID NCT02252172

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 study compared a three-drug combination (daratumumab, lenalidomide, and dexamethasone) against the standard two-drug regimen (lenalidomide and dexamethasone) in 737 people with newly diagnosed multiple myeloma who could not undergo high-dose chemotherapy and stem cell transplant. The goal was to see if the three-drug combo could delay cancer progression. Participants received treatment until the disease worsened or side effects became unacceptable, for up to 7 years.

What this could mean

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

Active substance
daratumumab, lenalidomide, and dexamethasone
What this could lead to
If successful, this combination could become a new standard treatment that delays disease progression in people with newly diagnosed multiple myeloma who cannot have a stem cell transplant.
What could go wrong
This is a completed phase 3 trial, so results are mature, but the treatment may not work for everyone and carries risks like infection, fatigue, and blood clots. It is not a cure, as ongoing therapy is needed.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

737 people

The number who actually took part.

Started

Feb 2015

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: * Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow greater than or equal to (\>=) 10 percent (%) or presence of a biopsy proven plasmacytoma and measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>=1.0 gram/deciliter \[g/dL\] or urine M-protein level \>=200 milligram\[mg\]/24 hours\[hrs\]; or (b) IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>=0.5 g/dL or urine M-protein level \>=200 mg/24 hrs); or (c) light chain multiple myeloma without measurable disease in serum or urine (serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age \>=65 years; or participants less than (\<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review and approval of participants below 65 years of age is required before randomization * Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab * Man, who is sexually active with a woman of child-bearing potential must agree to use a latex or synthetic condom, even if he had a successful vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab Exclusion Criteria: * Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein \<3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage) * Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions * Participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years) * Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment * Participant has had radiation therapy within 14 days of randomization * Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \<50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (controlled intermittent asthma or controlled mild persistent asthma is allowed) * Participants with known or suspected COPD must have a FEV1 test during Screening * Participant is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\] or antibodies to hepatitis B surface and core antigens \[anti-HBs and anti-HBc, respectively\]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid \[RNA\] quantitation positive)

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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

  • Study site

    Birmingham, Alabama, United States

  • Study site

    Mobile, Alabama, United States

  • Study site

    Glendale, Arizona, United States

  • Study site

    Berkeley, California, United States

  • Study site

    Beverly Hills, California, United States

  • Study site

    El Cajon, California, United States

  • Study site

    Greenbrae, California, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Oceanside, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    West Hills, California, United States

  • Study site

    Whittier, California, United States

  • Study site

    Denver, Colorado, United States

  • Study site

    Fort Collins, Colorado, United States

  • Study site

    Glenwood Springs, Colorado, United States

  • Study site

    New Haven, Connecticut, United States

  • Study site

    Norwalk, Connecticut, United States

  • Study site

    Washington D.C., District of Columbia, United States

  • Study site

    Boca Raton, Florida, United States

  • Study site

    Boynton Beach, Florida, United States

  • Study site

    Fort Lauderdale, Florida, United States

  • Study site

    Fort Myers, Florida, United States

  • Study site

    Hollywood, Florida, United States

  • Study site

    Jacksonville, Florida, United States

  • Study site

    Lake City, Florida, United States

  • Study site

    St. Petersburg, Florida, United States

  • Study site

    Weston, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Augusta, Georgia, United States

  • Study site

    Macon, Georgia, United States

  • Study site

    Marietta, Georgia, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Niles, Illinois, United States

  • Study site

    Fort Wayne, Indiana, United States

  • Study site

    Iowa City, Iowa, United States

  • Study site

    Louisville, Kentucky, United States

  • Study site

    Lafayette, Louisiana, United States

  • Study site

    Marrero, Louisiana, United States

  • Study site

    Shreveport, Louisiana, United States

  • Study site

    Annapolis, Maryland, United States

  • Study site

    Baltimore, Maryland, United States

  • Study site

    Frederick, Maryland, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Detroit, Michigan, United States

  • Study site

    Duluth, Minnesota, United States

  • Study site

    Rochester, Minnesota, United States

  • Study site

    Kansas City, Missouri, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Omaha, Nebraska, United States

  • Study site

    Hooksett, New Hampshire, United States

  • Study site

    Brick, New Jersey, United States

  • Study site

    Hackensack, New Jersey, United States

  • Study site

    Livingston, New Jersey, United States

  • Study site

    Plainfield, New Jersey, United States

  • Study site

    Summit, New Jersey, United States

  • Study site

    Mineola, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Rochester, New York, United States

  • Study site

    Asheboro, North Carolina, United States

  • Study site

    Charlotte, North Carolina, United States

  • Study site

    Pinehurst, North Carolina, United States

  • Study site

    Winston-Salem, North Carolina, United States

  • Study site

    Canton, Ohio, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Columbus, Ohio, United States

  • Study site

    Bend, Oregon, United States

  • Study site

    Bethlehem, Pennsylvania, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Spartanburg, South Carolina, United States

  • Study site

    Sioux Falls, South Dakota, United States

  • Study site

    Chattanooga, Tennessee, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Arlington, Texas, United States

  • Study site

    Edinburg, Texas, United States

  • Study site

    Fort Sam Houston, Texas, United States

  • Study site

    Fort Worth, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Plano, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Ogden, Utah, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Spokane, Washington, United States

  • Study site

    Tacoma, Washington, United States

  • Study site

    Box Hill, Australia

  • Study site

    Fitzroy, Australia

  • Study site

    Footscray, Australia

  • Study site

    Kogarah, Australia

  • Study site

    Kurralta Park, Australia

  • Study site

    Nedlands, Australia

  • Study site

    New South Wales, Australia

  • Study site

    Woodville, Australia

  • Study site

    Woolloongabba, Australia

  • Study site

    Innsbruck, Austria

  • Study site

    Linz, Austria

  • Study site

    Salzburg, Austria

  • Study site

    Vienna, Austria

  • Study site

    Wien Wien, Austria

  • Study site

    Bruges, Belgium

  • Study site

    Brussels, Belgium

  • Study site

    Haine Saint Paul La Louviere, Belgium

  • Study site

    Leuven, Belgium

  • Study site

    Liège, Belgium

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Nova Scotia, Nova Scotia, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Greenfield Park, Quebec, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Québec, Quebec, Canada

  • Study site

    N/a N/a, Canada

  • Study site

    Aarhus C, Denmark

  • Study site

    Odense, Denmark

  • Study site

    Vejle, Denmark

  • Study site

    Amiens N/a Picardie, France

  • Study site

    Angers, France

  • Study site

    Bayonne, France

  • Study site

    Bretagne, France

  • Study site

    Caen, France

  • Study site

    Cergy-Pontoise, France

  • Study site

    Chalon-sur-Saône, France

  • Study site

    Clermont-Ferrand, France

  • Study site

    Créteil, France

  • Study site

    Dijon, France

  • Study site

    Dunkirk, France

  • Study site

    Grenoble, France

  • Study site

    La Roche-sur-Yon, France

  • Study site

    Le Chesnay, France

  • Study site

    Le Mans, France

  • Study site

    Lille, France

  • Study site

    Limoges, France

  • Study site

    Lyon, France

  • Study site

    Marseille, France

  • Study site

    Metz-Tessy, France

  • Study site

    Montivilliers, France

  • Study site

    Montpellier, France

  • Study site

    Mulhouse, France

  • Study site

    Nantes, France

  • Study site

    Nice, France

  • Study site

    Paris, France

  • Study site

    Perpignan, France

  • Study site

    Pessac, France

  • Study site

    Périgueux, France

  • Study site

    Poitiers, France

  • Study site

    Reims, France

  • Study site

    Rennes, France

  • Study site

    Rouen, France

  • Study site

    Saint-Brieuc, France

  • Study site

    Saint-Priest-en-Jarez, France

  • Study site

    Saint-Quentin, France

  • Study site

    St-Malo, France

  • Study site

    Strasbourg, France

  • Study site

    Toulouse, France

  • Study site

    Tours, France

  • Study site

    Vandœuvre-lès-Nancy, France

  • Study site

    Aschaffenburg, Germany

  • Study site

    Bad Berka, Germany

  • Study site

    Bonn, Germany

  • Study site

    Braunschweig, Germany

  • Study site

    Dresden, Germany

  • Study site

    Essen, Germany

  • Study site

    Frankfurt, Germany

  • Study site

    Hanover, Germany

  • Study site

    Heidelberg, Germany

  • Study site

    Hessen, Germany

  • Study site

    Kiel, Germany

  • Study site

    Koblenz, Germany

  • Study site

    Mainz, Germany

  • Study site

    Mannheim, Germany

  • Study site

    Rostock, Germany

  • Study site

    Schwerin, Germany

  • Study site

    Stuttgart, Germany

  • Study site

    Tübingen, Germany

  • Study site

    Ulm, Germany

  • Study site

    Villingen-Schwenningen, Germany

  • Study site

    Dublin, Ireland

  • Study site

    Galway, Ireland

  • Study site

    Hadera, Israel

  • Study site

    Haifa, Israel

  • Study site

    Jerusalem, Israel

  • Study site

    Nahariya, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Tel Aviv, Israel

  • Study site

    Hilversum, Netherlands

  • Study site

    Hoofddorp, Netherlands

  • Study site

    Rotterdam, Netherlands

  • Study site

    Tilburg, Netherlands

  • Study site

    Falun, Sweden

  • Study site

    Gothenburg, Sweden

  • Study site

    Halmstad, Sweden

  • Study site

    Helsingborg, Sweden

  • Study site

    Huddinge, Sweden

  • Study site

    Luleå, Sweden

  • Study site

    Lund, Sweden

  • Study site

    Örebro, Sweden

  • Study site

    Stockholm, Sweden

  • Study site

    Aberdeen, United Kingdom

  • Study site

    Canterbury, United Kingdom

  • Study site

    Dundee, United Kingdom

  • Study site

    Leeds, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Manchester, United Kingdom

  • Study site

    Nottingham, United Kingdom

  • Study site

    Oxford, United Kingdom

  • Study site

    Plymouth, United Kingdom

  • Study site

    Southampton, United Kingdom

  • Study site

    Truro, United Kingdom

  • Study site

    Wolverhampton, United Kingdom

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