Combination of Lenalidomide and Autologous Mature Dendritic Cells Pulsed With KRN7000 in Myeloma

Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698776
• Other study ID #: 0712003357
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2008
• Last updated: June 20, 2016
• Start date: April 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• Age =18 years.

• 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:

• ANC =1500/µL

• PLT =100,000/µL

• Hemoglobin =8.0 g/dl

• Creatinine =2.0 mg/dL (Any elevation above normal range should not be felt to be related to myeloma)

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myeloma

Intervention

Drug:
• Lenalidomide
10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.

Biological:
• Monocyte derived DCs loaded with KRN7000
10 million DCs injected intravenously

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Celgene, Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Dose Limiting Toxicities (DLTs)		upon completion of treatment	Yes
Secondary	Number of Natural Killer Cells(NKT)that make IFN? in Vitro		upon completion of treatment	No