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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Kyowa Hakko Kirin Company, Limited
Celgene Corporation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00698776
First received: June 12, 2008
Last updated: May 5, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Myeloma
Drug: Lenalidomide
Biological: Monocyte derived DCs loaded with KRN7000
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate therapy induced activation of Vα24+Vβ11+ NKT cells in these patients. [ Time Frame: upon completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Revlimid
    • LEN
    Biological: Monocyte derived DCs loaded with KRN7000
    10 million DCs injected intravenously
    Other Names:
    • α-galactosyl-ceramide
    • α-GalCer
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698776

Contacts
Contact: Madhav Dhodapkar, MD 203-785-4144 madhav.dhodapkar@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Kyowa Hakko Kirin Company, Limited
Celgene Corporation
Investigators
Principal Investigator: Madhav Dhodapkar, MD Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madhav Dhodapkar, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00698776     History of Changes
Other Study ID Numbers: 0712003357
Study First Received: June 12, 2008
Last Updated: May 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
KRN 7000
Lenalidomide
Thalidomide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014