Multiple Myeloma Clinical Trial

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

705

Study ID:

NCT01850524

Recruitment Status:

Completed

Sponsor:

Millennium Pharmaceuticals, Inc.

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There is 1 Location for this study

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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

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Fullerton California, , United States

Irvine California, , United States

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Vallejo California, , United States

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Miami Florida, , United States

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Louisville Kentucky, , United States

Shreveport Louisiana, , United States

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Burlington Massachusetts, , United States

Worcester Massachusetts, , United States

Ann Arbor Michigan, , United States

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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

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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

Jeongnam , , 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

705

Study ID:

NCT01850524

Recruitment Status:

Completed

Sponsor:


Millennium Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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