Multiple Myeloma Clinical Trial
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
Male or female participants 18 years or older diagnosed with Multiple Myeloma according to standard criteria who have not received prior treatment for multiple myeloma.
Participants for whom lenalidomide and dexamethasone treatment is appropriate and who are not eligible for high-dose therapy followed by stem-cell transplantation (HDT-SCT) for 1 or more of the following reasons:
The participant is 65 years of age or older.
The participant is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT.
Measurable disease as specified in study protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Meet the clinical laboratories criteria as specified in the protocol.
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, and must also agree to ongoing pregnancy testing; must also adhere to the guidelines of the lenalidomide pregnancy prevention program.
Male participants who agree to practice effective barrier contraception or agree to practice true abstinence AND must adhere to the guidelines of the lenalidomide pregnancy prevention program.
Suitable venous access for the study-required blood sampling.
Must be able to take concurrent aspirin 70 mg to 325 mg daily (or enoxaparin if aspirin allergic).
Voluntary written consent.
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Prior treatment for multiple myeloma with either standard of care treatment or investigational regimen.
Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Inability or unwillingness to receive antithrombotic therapy.
Female participants who are lactating or pregnant.
Major surgery or radiotherapy within 14 days before randomization.
Infection requiring intravenous antibiotics within 14 days before the first dose of study drug.
Central nervous system involvement.
Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Evidence of current uncontrolled cardiovascular conditions within 6 months prior to randomization, including: Uncontrolled hypertension, cardiac arrhythmias, or congestive heart failure; Unstable angina, or Myocardial infarction.
Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin,itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study.
Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (e.g., peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).
Psychiatric illness/social situation that would limit compliance with study requirements.
Known allergy to any of the study medications.
Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
Treatment with any investigational products within 60 days before randomization.
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There is 1 Location for this study
Birmingham Alabama, , United States
Chandler Arizona, , United States
Tucson Arizona, , United States
Little Rock Arkansas, , United States
Anaheim California, , United States
Corona California, , United States
Fountain Valley California, , United States
Fullerton California, , United States
Irvine California, , United States
La Jolla California, , United States
Mission Hills California, , United States
Oakland California, , United States
Riverside California, , United States
San Diego California, , United States
San Jose California, , United States
San Leandro California, , United States
Santa Clara California, , United States
South San Francisco California, , United States
Vallejo California, , United States
Denver Colorado, , United States
Fort Collins Colorado, , United States
Hartford Connecticut, , United States
Plainville Connecticut, , United States
Fort Myers Florida, , United States
Jacksonville Florida, , United States
Miami Beach Florida, , United States
Miami Florida, , United States
West Palm Beach Florida, , United States
Atlanta Georgia, , United States
Marietta Georgia, , United States
Honolulu Hawaii, , United States
Iowa City Iowa, , United States
Sioux City Iowa, , United States
Louisville Kentucky, , United States
Shreveport Louisiana, , United States
Baltimore Maryland, , United States
Towson Maryland, , United States
Burlington Massachusetts, , United States
Worcester Massachusetts, , United States
Ann Arbor Michigan, , United States
Lansing Michigan, , United States
Southfield Michigan, , United States
Duluth Minnesota, , United States
Minneapolis Minnesota, , United States
Rochester Minnesota, , United States
Bridgeton Missouri, , United States
Kansas City Missouri, , United States
Little Silver New Jersey, , United States
Albuquerque New Mexico, , United States
Farmington New Mexico, , United States
Las Cruces New Mexico, , United States
Buffalo New York, , United States
Lake Success New York, , United States
New York New York, , United States
Poughkeepsie New York, , United States
Cincinnati Ohio, , United States
Cleveland Ohio, , United States
Tulsa Oklahoma, , United States
Eugene Oregon, , United States
Portland Oregon, , United States
Hershey Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Scranton Pennsylvania, , United States
Charleston South Carolina, , United States
Cookeville Tennessee, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Galveston Texas, , United States
San Antonio Texas, , United States
Temple Texas, , United States
Tyler Texas, , United States
Christiansburg Virginia, , United States
Richmond Virginia, , United States
Everett Washington, , United States
Seattle Washington, , United States
Spokane Washington, , United States
Vancouver Washington, , United States
Yakima Washington, , United States
Brussel Brussels, , Belgium
Bruxelles Brussels, , Belgium
Yvoir Namur, , Belgium
Gent Oost-Vlaanderen, , Belgium
Leuven Vlaams Brabant, , Belgium
Roeselare West-Vlaanderen, , Belgium
Bruges , , Belgium
Liege , , Belgium
Calgary Alberta, , Canada
Edmonton Alberta, , Canada
Surrey British Columbia, , Canada
Victoria British Columbia, , Canada
St. John New Brunswick, , Canada
Halifax Nova Scotia, , Canada
Hamilton Ontario, , Canada
London Ontario, , Canada
Toronto Ontario, , Canada
Fleurimont Quebec, , Canada
Levis Quebec, , Canada
Montreal Quebec, , Canada
Nice Alpes-Maritimes, , France
Strasbourg Bas-Rhin, , France
Brest Finistere, , France
Saint-Brieuc Finistere, , France
Limoges Haute-Vienne, , France
Castelnau-le-Lez Herault, , France
La Tronche Isere, , France
Nantes Loire-Atlantique, , France
Angers Maine-et-Loire, , France
Reims Marne, , France
Vandoeuvre-les-nancy Meurthe-et-Moselle, , France
Vannes Morbihan, , France
Lille Cedex Nord, , France
Lens Pas-de-Calais, , France
Saint-priest-en-jarez Rhone, , France
Montivilliers Seine-Maritime, , France
Poitiers Vienne, , France
Amiens , , France
Bayonne , , France
Bordeaux , , France
Caen , , France
Chalon sur Saone , , France
Creteil , , France
Dunkerque , , France
La Roche sur Yon , , France
Le Chesnay , , France
Le Mans cedex 2 , , France
Lille , , France
Montpellier cedex 5 , , France
Mulhouse , , France
Paris , , France
Perigueux , , France
Pierre Benite , , France
Pontoise , , France
Rouen , , France
TOULOUSE Cedex 9 , , France
Tours , , France
Goyang Gyeonggido, , Korea, Republic of
Seongnam-si Gyeonggido, , Korea, Republic of
Daegu , , Korea, Republic of
Daejeon , , Korea, Republic of
Incheon , , Korea, Republic of
Jeonnam , , Korea, Republic of
Seoul , , Korea, Republic of
Auckland North Island, , New Zealand
Wellington North Island, , New Zealand
Christchurch South Island, , New Zealand
Dunedin South Island, , New Zealand
Hamilton , , New Zealand
Ryazan , , Russian Federation
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