A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Daratumumab, Lenalidomide, Dexamethasone
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Daratumumab Type: Drug
Name: Lenalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.
Detailed Description
This is a randomized (participants will be assigned by chance to study treatments), open-label (all participants and study personnel will know the identity of the study treatments), active-controlled (none of the study treatments are placebo), parallel-group (both treatment arms will run at the same time), multicenter study. In this study, daratumumab, lenalidomide, and low-dose dexamethasone (DRd) will be compared with lenalidomide and low dose dexamethasone (Rd) in participants with relapsed or refractory multiple myeloma. Participants will be randomized in a 1:1 ratio to receive either DRd or Rd. The study will include a Screening Phase, a Treatment Phase (involving treatment cycles of approximately 28 days in length), and a Follow-up Phase. The Treatment Phase will extend from the administration of the first dose of study medication until disease progression or unacceptable toxicity. Participants will also discontinue study treatment if: they become pregnant; have their dose held for more than 28 days (or if 3 consecutive planned doses of daratumumab are missed for reasons other than toxicity); or for safety reasons (for example, adverse event). The Follow-up Phase will begin at the end of treatment and will continue until death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. The primary endpoint will be progression-free survival (PFS). Analysis of the primary endpoint is anticipated to be performed at approximately 18 months after the last subject is randomized. Study end is anticipated at approximately 5 years after the last subject is randomized. Blood and urine samples will be obtained at time points during the study, together with bone marrow aspirates/biopsies and skeletal surveys. Participant safety will be assessed throughout the study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Must have documented multiple myeloma and measurable disease

- Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen

- Must have documented evidence of progressive disease as defined by the International Myeloma Working Group criteria on or after their last regimen

- Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

Exclusion Criteria:

- Has received any of the following therapies: daratumumab or other anti-CD38 therapies

- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment

- Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment

- Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease

- History of malignancy (other than multiple myeloma) within 5 years before the date of randomization
Locations
Birmingham, Alabama, United States
Status: Withdrawn
Little Rock, Arkansas, United States
Status: Completed
Los Angeles, California, United States
Status: Withdrawn
Gainesville, Florida, United States
Status: Completed
Jacksonville, Florida, United States
Status: Withdrawn
West Palm Beach, Florida, United States
Status: Recruiting
Atlanta, Georgia, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Withdrawn
Iowa City, Iowa, United States
Status: Active, not recruiting
Louisville, Kentucky, United States
Status: Completed
Baton Rouge, Louisiana, United States
Status: Completed
New Orleans, Louisiana, United States
Status: Completed
Bethesda, Maryland, United States
Status: Completed
Columbia, Maryland, United States
Status: Completed
Boston, Massachusetts, United States
Status: Active, not recruiting
Chicago, Michigan, United States
Status: Active, not recruiting
Rochester, Minnesota, United States
Status: Active, not recruiting
Great Falls, Montana, United States
Status: Withdrawn
Omaha, Nebraska, United States
Status: Active, not recruiting
New Brunswick, New Jersey, United States
Status: Completed
New York, New York, United States
Status: Withdrawn
New York, New York, United States
Status: Recruiting
New York, New York, United States
Status: Active, not recruiting
New York, New York, United States
Status: Completed
Chapel Hill, North Carolina, United States
Status: Withdrawn
Charlotte, North Carolina, United States
Status: Active, not recruiting
Eugene, Oregon, United States
Status: Active, not recruiting
Portland, Oregon, United States
Status: Withdrawn
Philadelphia, Pennsylvania, United States
Status: Withdrawn
Spartanburg, South Carolina, United States
Status: Completed
Austin, Texas, United States
Status: Recruiting
Dallas, Texas, United States
Status: Active, not recruiting
Houston, Texas, United States
Status: Active, not recruiting
Fairfax, Virginia, United States
Status: Completed
Fairfax, Virginia, United States
Status: Withdrawn
Seattle, Washington, United States
Status: Withdrawn
Madison, Wisconsin, United States
Status: Withdrawn
Camperdown, Australia
Status: Active, not recruiting
Concord, Australia
Status: Withdrawn
Geelong, Australia
Status: Completed
Gosford, Australia
Status: Withdrawn
Heidelberg, Australia
Status: Completed
Malvern, Australia
Status: Active, not recruiting
Nedlands, Australia
Status: Withdrawn
South Brisbane, Australia
Status: Active, not recruiting
Southport, Australia
Status: Active, not recruiting
Westmead, Australia
Status: Withdrawn
Antwerpen, Belgium
Status: Active, not recruiting
Brussel, Belgium
Status: Active, not recruiting
Edegem, Belgium
Status: Active, not recruiting
Gent, Belgium
Status: Active, not recruiting
Kortrijk, Belgium
Status: Active, not recruiting
Leuven, Belgium
Status: Active, not recruiting
Liege, Belgium
Status: Completed
Calgary, Alberta, Canada
Status: Active, not recruiting
Edmonton, Alberta, Canada
Status: Active, not recruiting
Vancouver, British Columbia, Canada
Status: Active, not recruiting
Winnipeg, Manitoba, Canada
Status: Withdrawn
St. John'S, Newfoundland and Labrador, Canada
Status: Withdrawn
Halifax, Nova Scotia, Canada
Status: Active, not recruiting
Hamilton, Ontario, Canada
Status: Active, not recruiting
London, Ontario, Canada
Status: Active, not recruiting
Montreal, Quebec, Canada
Status: Withdrawn
Montreal, Quebec, Canada
Status: Active, not recruiting
Quebec City, Quebec, Canada
Status: Active, not recruiting
Surrey N/A, Canada
Status: Active, not recruiting
Toronto N/A, Canada
Status: Active, not recruiting
Copenhagen, Denmark
Status: Active, not recruiting
Odense, Denmark
Status: Active, not recruiting
Vejle, Denmark
Status: Active, not recruiting
Argenteuil, France
Status: Active, not recruiting
Caen, France
Status: Active, not recruiting
Lille, France
Status: Active, not recruiting
Limoges, France
Status: Active, not recruiting
Nantes Cedex 1, France
Status: Active, not recruiting
Paris, France
Status: Active, not recruiting
Pessac, France
Status: Active, not recruiting
Pierre Benite, France
Status: Active, not recruiting
Rennes, France
Status: Active, not recruiting
Toulouse Cedex 9, France
Status: Active, not recruiting
Tours Cedex 9, France
Status: Active, not recruiting
Vandoeuvre Les Nancy, France
Status: Active, not recruiting
Berlin, Germany
Status: Active, not recruiting
Berlin, Germany
Status: Withdrawn
Bonn, Germany
Status: Active, not recruiting
Essen, Germany
Status: Withdrawn
Freiburg, Germany
Status: Withdrawn
Hamburg, Germany
Status: Active, not recruiting
Hamm, Germany
Status: Active, not recruiting
Heidelberg, Germany
Status: Active, not recruiting
Jena, Germany
Status: Recruiting
Karlsruhe, Germany
Status: Completed
Koblenz, Germany
Status: Active, not recruiting
Köln, Germany
Status: Active, not recruiting
Potsdam, Germany
Status: Withdrawn
Saarbrücken, Germany
Status: Active, not recruiting
Villingen-Schwenningen, Germany
Status: Completed
Würzburg, Germany
Status: Withdrawn
Athens Attica, Greece
Status: Active, not recruiting
Ashkelon, Israel
Status: Withdrawn
Haifa, Israel
Status: Withdrawn
Haifa, Israel
Status: Active, not recruiting
Jerusalem, Israel
Status: Active, not recruiting
Nahariya, Israel
Status: Active, not recruiting
Netanya, Israel
Status: Active, not recruiting
Petah Tikva, Israel
Status: Active, not recruiting
Ramat Gan, Israel
Status: Active, not recruiting
Ramat Gan, Israel
Status: Withdrawn
Tel Aviv, Israel
Status: Active, not recruiting
Fukuoka, Japan
Status: Withdrawn
Hiroshima, Japan
Status: Withdrawn
Hitachi, Japan
Status: Active, not recruiting
Kanazawa, Japan
Status: Active, not recruiting
Kawagoe, Japan
Status: Withdrawn
Kobe, Japan
Status: Active, not recruiting
Kurume, Japan
Status: Completed
Matsuyama, Japan
Status: Recruiting
Nagoya, Japan
Status: Active, not recruiting
Narita, Japan
Status: Active, not recruiting
Ohgaki, Japan
Status: Recruiting
Okayama, Japan
Status: Recruiting
Osaka, Japan
Status: Active, not recruiting
Osaka, Japan
Status: Completed
Sendai, Japan
Status: Active, not recruiting
Shibukawa, Japan
Status: Active, not recruiting
Tachikawa, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Completed
Gyeonggi-Do, Korea, Republic of
Status: Active, not recruiting
Incheon, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Amsterdam, Netherlands
Status: Active, not recruiting
Rotterdam, Netherlands
Status: Completed
Utrecht, Netherlands
Status: Completed
Zwolle, Netherlands
Status: Completed
Brzozów, Poland
Status: Recruiting
Chorzów, Poland
Status: Active, not recruiting
Gdansk, Poland
Status: Active, not recruiting
Legnica, Poland
Status: Active, not recruiting
Lodz, Poland
Status: Withdrawn
Lublin, Poland
Status: Active, not recruiting
Olsztyn, Poland
Status: Withdrawn
Poznan, Poland
Status: Active, not recruiting
Slupsk, Poland
Status: Active, not recruiting
Wroclawa, Poland
Status: Active, not recruiting
Arkhangelsk, Russian Federation
Status: Withdrawn
Dzerzhinsk, Russian Federation
Status: Active, not recruiting
Ekaterinburg, Russian Federation
Status: Active, not recruiting
Krasnodar, Russian Federation
Status: Withdrawn
Moscow, Russian Federation
Status: Active, not recruiting
Moscow, Russian Federation
Status: Withdrawn
Nizhny Novgorod, Russian Federation
Status: Active, not recruiting
Obninsk, Russian Federation
Status: Withdrawn
Petrozavodsk, Russian Federation
Status: Active, not recruiting
Pyatigorsk, Russian Federation
Status: Withdrawn
Rostov-Na-Donu, Russian Federation
Status: Withdrawn
Rostov-On-Don, Russian Federation
Status: Withdrawn
Ryazan, Russian Federation
Status: Active, not recruiting
Saint Petersburg, Russian Federation
Status: Withdrawn
Samara, Russian Federation
Status: Active, not recruiting
Sochi, Russian Federation
Status: Withdrawn
St-Petersburg, Russian Federation
Status: Active, not recruiting
St. Petersburg, Russian Federation
Status: Active, not recruiting
Syktyvkar, Russian Federation
Status: Active, not recruiting
Badalona, Spain
Status: Active, not recruiting
Barcelona, Spain
Status: Recruiting
La Laguna (Santa Cruz De Tenerife), Spain
Status: Active, not recruiting
Madrid, Spain
Status: Active, not recruiting
Pamplona, Spain
Status: Active, not recruiting
Salamanca N/A, Spain
Status: Active, not recruiting
Sevilla, Spain
Status: Completed
Falun, Sweden
Status: Active, not recruiting
Göteborg, Sweden
Status: Active, not recruiting
Helsingborg, Sweden
Status: Active, not recruiting
Huddinge, Sweden
Status: Recruiting
Lund, Sweden
Status: Active, not recruiting
Stockholm, Sweden
Status: Active, not recruiting
Uppsala, Sweden
Status: Active, not recruiting
Changhua, Taiwan
Status: Completed
Taichung City, Taiwan
Status: Active, not recruiting
Tainan, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Active, not recruiting
Taoyuan, Taiwan
Status: Active, not recruiting
Aberdeen, United Kingdom
Status: Withdrawn
Birmingham, United Kingdom
Status: Active, not recruiting
Eastbourne, United Kingdom
Status: Withdrawn
Leeds, United Kingdom
Status: Active, not recruiting
London, United Kingdom
Status: Active, not recruiting
Oxford, United Kingdom
Status: Active, not recruiting
Southampton, United Kingdom
Status: Active, not recruiting
Surrey, United Kingdom
Status: Active, not recruiting
Wolverhampton, United Kingdom
Status: Active, not recruiting
Start Date
May 2014
Completion Date
September 2020
Sponsors
Janssen Research & Development, LLC
Source
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page