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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Celgene Corporation
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
First received: January 14, 2010
Last updated: April 29, 2015
Last verified: April 2015

January 14, 2010
April 29, 2015
January 2010
August 2014   (final data collection date for primary outcome measure)
Feasibility 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 ClinicalTrials.gov 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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
January 2017
August 2014   (final data collection date for primary outcome measure)


  • Patients with a diagnosis of multiple myeloma
  • Eligible to undergo an autologous stem cell transplant
  • Has residual measurable disease (in partial remission [PR] or with stable disease)
  • Measurable disease:
  • quantifiable serum
  • urinary M protein
  • free light chains in the presence of a positive immunofixation
  • bone marrow plasma cells >5% NOTE: Isolated bone lytic lesions in the absence of measurable para-proteins will not be considered measurable disease
  • received prior lenalidomide therapy will be eligible (if >PR was observed or did not progress on lenalidomide containing regimen)
  • Progression following discontinuation of prior therapy with lenalidomide is allowed as long as patients have not failed rechallenge with lenalidomide
  • A minimum period of two weeks must have elapsed following the prior myeloma therapy (this does not include therapy with bisphosphonates)
  • Patients ages ≤ 18 and <70 years of age
  • ECOG performance status ≤ 2
  • Negative serology for HIV
  • Serum bilirubin ≤ 1.5 times
  • Creatinine clearance >60 ml/min or or serum creatinine ≤ 2.0 mg/dL
  • ANC≥1500/L
  • platelet count ≥100,000/L
  • Hemoglobin ≥10 g/dL
  • No clinical evidence of uncontrolled viral, fungal, bacterial infection
  • Cardiac and pulmonary function adequate for transplant
  • Ability to sign informed consent
  • Registered into mandatory RevAssist program and comply with requirements
  • Females of childbearing potential (FCBP)† must have:
  • Negative serum or urine pregnancy test within 10 - 14 days prior to, within 24 hours of prescribing lenalidomide
  • Either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control at least 28 days before treatment.
  • Agree to ongoing pregnancy testing
  • Men must agree to use a latex condom during sexual contact with FCBP


  • Known or suspected hypersensitivity to azacitidine or mannitol
  • Patients with MM refractory to therapy with lenalidomide
  • Pregnant or breast feeding
  • Other concomitant malignancies
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Concurrent use of other anti-cancer agents or treatments
  • Known hypersensitivity to thalidomide or lenalidomide
18 Years to 70 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
April 2015

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