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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

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

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

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

- 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

- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation
(patients intolerant to ASA may use warfarin or low molecular weight

(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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

upon completion of treatment

Safety Issue:


Principal Investigator

Madhav Dhodapkar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

May 2011

Related Keywords:

  • Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Yale University School Of Medicine New Haven, Connecticut  06520