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Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: January 14, 2010
Last updated: December 19, 2014
Last verified: December 2014

January 14, 2010
December 19, 2014
January 2010
August 2014   (final data collection date for primary outcome measure)
Ability to mobilize and infuse autologous lymphocytes (ALI) after immunomodulatory therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Ability to mobilize and infuse autologous lymphocytes (ALI) after immunomodulatory therapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01050790 on Archive Site
  • Complete response rate at 6 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Pre- and post-ALI immune response to cancer testis antigens (CTA) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • CTA expression before and after azacitidine therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Complete response rate at 6 months [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Pre- and post-ALI immune response to cancer testis antigens (CTA) [ Designated as safety issue: No ]
  • CTA expression before and after azacitidine therapy [ Designated as safety issue: No ]
Not Provided
Not Provided
Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma
Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy

RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by lenalidomide and azacitidine. Giving autologous lymphocytes after the transplant may help destroy any remaining cancer cells.

PURPOSE: This phase I trial is studying how well giving lenalidomide together with azacitidine works when followed by autologous stem cell transplant and autologous lymphocyte infusion in treating patients with multiple myeloma.



  • Determine the feasibility of mobilizing and infusing autologous lymphocytes (ALI) following immunomodulatory therapy comprising azacitidine and lenalidomide in patients with multiple myeloma.


  • Determine the ability to proceed with autologous stem cell transplantation in these patients.
  • Determine the complete response rate at 6 months following transplant in patients treated with this regimen.
  • Determine the progression-free survival and overall survival of patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.
  • Monitor the toxicity of post-autologous stem cell infusion of autologous lymphocytes.
  • Measure the pre- and post-ALI immune response to cancer testis antigens (CTA) (CTA-specific Ig and T-cell repertoire).
  • Study the expression of CTA in multiple myeloma before and after azacitidine therapy.


  • Immunomodulatory therapy: Patients receive azacitidine subcutaneously on days 1-5 and oral lenalidomide on days 6-21. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
  • Lymphapheresis: Patients undergo autologous lymphocyte harvest on day 22 of courses 2 and 3.
  • Autologous stem cell transplantation (ASCT): Patients undergo single or tandem ASCT using standard protocols.
  • Autologous lymphocyte infusion (ALI): Patients undergo ALI approximately 28-60 days after ASCT.

Blood samples are collected at baseline and periodically during study for correlative laboratory studies, including CTA-specific immune monitoring by RT-PCR, ELISPOT assays, and flow cytometry. Tissue samples from bone marrow aspirates are also collected at baseline, during course one, and after course three for CTA expression and methylation studies.

After completion of study therapy, patients are followed periodically.

Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: azacitidine
    75 mg/sq m daily for 5 days
    Other Name: Vidaza®
  • Drug: lenalidomide
    10 mg p.o. daily, Days 6-21
    Other Names:
    • CC-5013
    • Revlimid®
Experimental: 5-azacytidine + lenalidomide -> auto stem cell transplant
  • Drug: azacitidine
  • Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
January 2017
August 2014   (final data collection date for primary outcome measure)


  • Diagnosis of multiple myeloma (MM)

    • Has residual measurable disease* (in partial remission [PR] or with stable disease), as defined by either of the following:

      • Quantifiable levels of serum or urinary M protein or free-light chains in the presence of a positive immunofixation
      • Bone marrow plasma cells > 5% NOTE: *Isolated lytic bone lesions in the absence of measurable para-proteins not considered measurable disease
  • Not refractory to lenalidomide

    • At least a PR was observed on a prior lenalidomide-containing regimen AND patient did not progress while receiving lenalidomide
    • Patients who progress after discontinuation of lenalidomide treatment are eligible provided they have not failed rechallenge with lenalidomide
  • Eligible to undergo autologous stem cell transplantation (ASCT)

    • Meets the requirements for ASCT per Virginia Commonwealth University BMT SOP 6.00


  • ECOG performance status 0-2
  • ANC ≥ 2,000/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 10 g/dL
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and/or SGPT ≤ 3 times ULN
  • Creatinine clearance ≥ 60 mL/min OR serum creatinine ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use two effective methods of contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy
  • Registered in the RevAssist® program AND willing and able to comply with the requirements of RevAssist®
  • Adequate cardiac and pulmonary function for transplant
  • No known HIV positivity
  • No clinical evidence of uncontrolled viral, fungal, or bacterial infection
  • No known or suspected hypersensitivity to azacitidine, mannitol, thalidomide, or lenalidomide
  • No other concurrent malignancies
  • No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent


  • See Disease Characteristics
  • At least 2 weeks since prior myeloma therapy (other than bisphosphonates)

    • Concurrent bisphosphonates allowed
  • No other concurrent anticancer agents or treatments
18 Years to 69 Years
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000663409, P30CA016059, MCC-12430
Virginia Commonwealth University
Virginia Commonwealth University
  • National Cancer Institute (NCI)
  • Celgene Corporation
Principal Investigator: Amir A. Toor, MD Massey Cancer Center
Virginia Commonwealth University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP