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Combination of Lenalidomide and Autologous Mature Dendritic Cells Pulsed With KRN7000 in Myeloma
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II, Phase I | Treatment | Active | 18 and over | 0712003357 NCT00698776 |
Trial Description
Summary This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients. Eligibility Criteria Inclusion Criteria: - Previously untreated asymptomatic multiple myeloma
- Prior therapy: Patients cannot have received prior thalidomide, lenalidomide or corticosteroids for the intent of treating their myeloma. Prior corticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use should be restricted to the equivalent of prednisone 10 mg per day or less. Prior radiation therapy for the treatment of solitary plasmacytoma is permitted, but more than 3 months should have elapsed from the last day of radiation.
- Measurable disease as defined by one of the following:
- Serum monoclonal protein ≥1.0 g by protein electrophoresis
- >200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Measurable soft tissue plasmacytoma.
- ≥10% plasma cells as measured on the bone marrow aspirate or bone marrow biopsy.
- ECOG Performance status 0, 1, or 2.
- Willing to provide written informed consent.
- All study participants must be registered into the mandatory RevAssistSM program, and be willing and able to comply with the requirements of RevAssistSM.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). (b) Laboratory inclusion criteria obtained ≤ 1 month prior to registration:
- Creatinine ≤2.0 mg/dL (Any elevation above normal range should not be felt to be related to myeloma)
Exclusion Criteria: - Another active malignancy.
- Immediate need for chemotherapy in the opinion of the treating physician.
- New York Heart Association classification III or IV.
- Existing ≥Grade 2 neuropathy.
- This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
- Active systemic autoimmunity (e.g. systemic lupus erythematosus
Trial Contact Information
Trial Lead Organizations/Sponsors Yale Cancer Center Kyowa Hakko Kirin Company, Limited
Celgene Corporation
Madhav Dhodapkar, MD | | Principal Investigator |
Trial Sites
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U.S.A. |
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Connecticut |
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New Haven |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00698776 Information obtained from ClinicalTrials.gov on May 06, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
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