June 12, 2008 |
May 5, 2009 |
April 2009 |
To examine the tolerability of the combination of Lenalidomide (LEN) and monocyte-derived mature DCs pulsed with α-galactosyl-ceramide (α-GalCer;
KRN7000) in myeloma patients. [ Time Frame: upon completion of treatment ] [ Designated as safety issue: Yes ] |
Same as current |
Complete list of historical versions of study NCT00698776 on ClinicalTrials.gov Archive Site |
To evaluate therapy induced activation of Vα24+Vβ11+ NKT cells in these patients. [ Time Frame: upon completion of treatment ] [ Designated as safety issue: No ] |
Same as current |
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Combination of Lenalidomide and Autologous Mature Dendritic Cells Pulsed With KRN7000 in Myeloma |
Phase I/II Trial of Combination of Lenalidomide (Revlimid, LEN) and Autologous Mature Dendritic Cells Pulsed With α-Galactosyl Ceramide (α-GalCer; KRN7000) in Myeloma |
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. |
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Phase I, Phase II |
Interventional |
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Myeloma |
- Drug: Lenalidomide
- Biological: Monocyte derived DCs loaded with KRN7000
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Recruiting |
36 |
May 2011 |
May 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Solitary plasmacytoma.
- Uncontrolled infection.
- 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.
Any of the following:
- Pregnant women
- Nursing women
- 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
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Both |
18 Years and older |
No |
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United States |
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NCT00698776 |
Madhav Dhodapkar, M.D., Yale University School of Medicine |
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Yale University |
- Kyowa Hakko Kirin Company, Limited
- Celgene Corporation
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Principal Investigator: |
Madhav Dhodapkar, MD |
Yale University |
|
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Yale University |
May 2009 |