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

June 20, 2016 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Dose Limiting Toxicities (DLTs)
Time Frame: upon completion of treatment
upon completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Natural Killer Cells(NKT)that make IFNγ in Vitro
Time Frame: upon completion of treatment
upon completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Celgene
Kyowa Kirin Co., Ltd.

Investigators

  • Principal Investigator: Madhav Dhodapkar, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0712003357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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