Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

Completed · Phase 1

Conditions studied: Relapsed Multiple Myeloma

In brief

To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma

Key facts

Study ID

NCT00603447

Run by

Amgen

People needed

84

Starts

2008-05-01

Expected to finish

2016-01-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease related:
• Symptomatic multiple myeloma
• Relapsed or progressive disease after at least one but no more than three prior therapeutic treatments or regimens for multiple myeloma
• Prior therapeutic treatment regimens may have included bortezomib, lenalidomide, and/or thalidomide, among other agents.
• If previously treated with lenalidomide or bortezomib, the subject must not have progressed during the first 3 months of treatment with the drug and must not have discontinued treatment due to lenalidomide intolerance (bortezomib intolerant subjects may enroll).
• Measurable disease, as indicated by one or more of the following:
• Serum M-protein ≥ 0.5 g/dL
• Urine Bence-Jones protein ≥ 200 mg/24 h
• If Serum Protein Electrophoresis is felt to be unreliable for routine M-protein measurement (particularly for patients with Immunoglobulin (Ig)A multiple myeloma), then quantitative immunoglobulin levels can be accepted.
• Prior to enrollment, sites must provide evidence of myeloma progression/relapse, with start and stop dates of the most recent treatment regimen, as well as best tumor response to all prior treatment regimens.
• Demographic
• Males and females ≥ 18 years of age
• Life expectancy of more than three months
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Laboratory
• Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) < 3 times ULN
• Absolute neutrophil count (ANC) ≥ 1,000/mm³, hemoglobin ≥ 8 gm/dL, platelet count ≥ 50,000/ mm³ (≥ 30 × 10\^9/L if myeloma involvement in the bone marrow is > 50%)
• Screening ANC should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks.
• Subjects may receive red blood cell (RBC) or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
• Screening platelet count should be independent of platelet transfusions for at least 2 weeks
• Calculated or measured creatinine clearance of ≥ 50 mL/minute, calculated using the formula of Cockcroft and Gault [(140 - Age) x Mass (kg) / (72 x creatinine mg/dL)]; multiply result by 0.85 (if female). Other generally accepted calculation methods can be substituted.
• Ethical/Other
• Written informed consent in accordance with federal, local, and institutional guidelines
• Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing
• FCBP* must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL within 10-14 days (US/RevAssist®) or 25 mIU/mL within 7-14 days (Canada/RevAidSM), prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or to use two methods of reliable birth control, including at least one highly effective method AND one additional effective method of birth control (contraception) AT THE SAME TIME, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during therapy delay, and continuing for 4 weeks following discontinuation of lenalidomide therapy. If a hormonal method (birth control pills, injections, patch or implants) or intrauterine device (IUD) is not medically possible for the subject, the subject may use another highly effective method or two barrier methods AT THE SAME TIME.

You may not qualify if…

• Disease related
• Subjects with non-secretory or hyposecretory multiple myeloma, defined as < 0.5 g/dL M-protein in serum, < 200 mg/24 hr Bence Jones protein in urine, or disease only measured by serum free light chain (FLC)
• Subjects who never achieved at least a durable minimal response (MR, ≥ 25% reduction in M-protein for at least 6 weeks) on any prior therapy
• Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 4 mg/day or prednisone ≥ 20 mg/day within 3 weeks prior to first dose
• Use of any other experimental drug or therapy within 28 days of baseline
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia
• Waldenström's macroglobulinemia
• Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 3 weeks prior to first dose
• Radiation therapy or immunotherapy within 4 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
• Planned radiation therapy that occurs after the start of treatment
• Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater.
• Concurrent conditions
• Pregnant or lactating females
• History of allergy to boron or mannitol
• Major surgery within 3 weeks prior to first dose
• Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
• Uncontrolled hypertension
• Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
• Known or suspected human immunodeficiency virus (HIV) infection, known HIV seropositivity, or active hepatitis A, B, or C infection
• Non-hematologic malignancy within the past three years except
• adequately treated basal cell or squamous cell skin cancer,
• carcinoma in situ of the cervix, or
• prostate cancer < Gleason Grade 6 with stable prostate specific antigen (PSA) levels
• Serious psychiatric or medical conditions that could interfere with treatment

Where it is running

• Pacific Shores Medical Group — Long Beach, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Cornell University — New York, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutch Cancer Research Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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