Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

Background: \- Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group. Objectives: \- To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. Eligibility: \- People at least 18 years of age who have multiple myeloma that has not been treated. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies. * Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease. * After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns. * After stem cell collection, participants will have the second four treatment cycles. -, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone. * Participants will have regular follow-up visits after the end of the study chemotherapy.

Key facts

Study ID

NCT01402284

Run by

National Cancer Institute (NCI)

People needed

45

Starts

2011-07-21

Expected to finish

2020-09-24

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior or concurrent systemic treatment for MM.
• Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids is permitted.
• Bisphosphonates are permitted.
• Treatment with corticosteroids for indications other than MM is permitted.
• Radiotherapy is permitted.
• Treatment for smoldering myeloma is permitted.
• Plasma cell leukemia
• Pregnant or lactating females. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with carfilzomib in combination with lenalidomide, breastfeeding should be discontinued if the mother is treated with carfilzomib and lenalidomide. These potential risks may also apply to other agents used in this study.
• Uncontrolled hypertension or diabetes
• Active hepatitis B or C infection
• Has significant cardiovascular disease with New York Heart Association (NYHA) Class III or IV symptoms, or hypertrophic cardiomyopathy, or restrictive cardiomyopathy, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia as determined by history and physical examination. Echocardiogram will be performed if clinically warranted.
• Has refractory gastrointestinal (GI) disease with refractory nausea/vomiting, inflammatory bowel disease, or bowel resection that would prevent absorption
• Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
• Significant neuropathy greater than or equal to Grade 3 at baseline
• Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
• Major surgery within 1 month prior to enrollment
• Recruitment Strategies:
• Patients that progress from the smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS) Natural History Study (NCI Protocol: 10-C-0096) will be potential candidates.
• Other participant sources will be from outside physician referrals.
• Our ongoing natural history study and outside physician referral network has a high representation of minorities.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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