Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	Other	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.

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Yale Cancer Center

Madhav Dhodapkar, MD

Principal Investigator

Madhav Dhodapkar, MD		Ph: 203-785-4144
		Email: madhav.dhodapkar@yale.edu

U.S.A.
Connecticut
	New Haven
	Yale Cancer Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00698776
Information obtained from ClinicalTrials.gov on May 06, 2009