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Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide Compared to Lenalidomide Alone in Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT03376477
Recruitment Status : Not yet recruiting
First Posted : December 18, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
Celgene
Aduro Biotech, Inc.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The investigator's primary objective is to compare the 2-year progression free survival of patients treated with lenalidomide alone or in combination with vaccine

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: GM-CSF vaccine Drug: Lenalidomide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either lenalidomide alone or in combination with vaccine. Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. All patients will be followed for a minimum of 3 years.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of an Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide Compared to Lenalidomide Alone in Multiple Myeloma Patients in Complete or Near Complete Remission
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 16, 2020
Estimated Study Completion Date : October 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Lenalidomide plus GM-CSF Vaccine

Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.

Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter.

Biological: GM-CSF vaccine
Each vaccination will consist of three total intra-dermal injections, one each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Vaccine injections sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each vaccination injection is approximately 0.3-0.4ml.

Drug: Lenalidomide
Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5-25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Active Comparator: Lenalidomide Only
Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment
Drug: Lenalidomide
Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5-25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).




Primary Outcome Measures :
  1. 2-year progression free survival [ Time Frame: 2 years ]
    • To compare the 2-year progression free survival of patients treated with lenalidomide alone or in combination with vaccine.


Secondary Outcome Measures :
  1. CR Conversion Rate [ Time Frame: 3 years ]
    Determine the rate of conversion from near CR (immunofixation positive) to true CR (immunofixation negative)

  2. MRD Conversion Rate [ Time Frame: 3 years ]
    Determine the rate of conversion from MRD (Minimal Residual Disease) positive status to MRD negative status by NGS (next generation sequencing).

  3. Time to Response [ Time Frame: 3 Years ]
  4. Progression Free Survival [ Time Frame: 5 years ]
    Determine progression free survival at 3 and 5 years.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Myeloma eligibility criteria are the following:
  • Near complete remission (nCR) for ≥ 3 months defined as no measurable M-spike, and a positive serum immunofixation
  • Or complete remission (CR) (no measurable M-spike, immunofixation negative and bone marrow plasma cells <5%)
  • NDMM or RMM in nCR or CR having completed a minimum of 6 cycles of a lenalidomide based regimen for a minimum of ≥ 3 months
  • NDMM or RMM a patients who have been off corticosteroids for ≥ 4 weeks
  • Patients with NDMM or RMM who have had autologous stem cell transplant are eligible, but must be ≥ 12 months from transplant
  • Age >18 years
  • ECOG performance scores 0-2
  • History of measurable serum or urine M protein or free light chains
  • Life expectancy greater than 12 months
  • Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia
  • Serum creatinine< 2 mg/dl
  • ANC >1000/µL
  • Platelet >100,000/µL
  • Total bilirubin <= 1.5 x ULN
  • AST (SGOT) and ALT (SGPT) <= 3 x ULN.
  • Ability to comprehend and have signed the informed consent.
  • Have previously agreed to continue on maintenance therapy with lenalidomide concurrent with vaccine administration until disease progression, or clinical indication to cease therapy.
  • Disease free of prior malignancies for at least 5 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the uterus, cervix or breast.
  • All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to starting lenalidomide with each cycle (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 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
  • Able to take prophylactic anticoagulation (aspirin 81 or 325 mg/daily or, for patients intolerant to ASA, warfarin or low molecular weight heparin).

Exclusion Criteria:

  • Disease progression after stopping corticosteroids as defined as the appearance of a detectable serum or urine M-spike, or an absolute increase of >10 mg/dl between involved and uninvolved light chains, in the absence of measurable serum or urine M-protein .
  • Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma and amyloidosis
  • High-risk myeloma defined by presence of at least one of the following defining features on initial diagnostic, or most recent bone marrow biopsy:
  • High risk chromosomal translocations by FISH: t(4;14), t(14;16), t(14;20),
  • del(17p), del(1p), amplification 1q.;
  • MyPRS GEP-70 high risk signature either from diagnosis or at time of registration for the study;
  • LDH > 300 U/L at diagnosis;
  • Relapse from prior therapy within 12 months.
  • HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
  • Patients who have participated in any clinical trial, within the last four weeks, which involved an investigational drug.
  • History of an active malignancy other than myeloma
  • Autoimmune disease requiring active treatment.
  • Known contra-indication to any component of allogeneic myeloma vaccine
  • History of an allogeneic transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376477


Contacts
Contact: Syed A Ali, MD 443-287-7104 sali35@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Syed A Ali, MD    443-287-7104    sali35@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Celgene
Aduro Biotech, Inc.
Investigators
Principal Investigator: Syed A Ali, MD Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03376477     History of Changes
Other Study ID Numbers: J16118
IRB00112179 ( Other Identifier: JHMIRB )
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Lenalidomide
M-spike negative
GVax
GM-CSF secreting myeloma vaccine

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
Vaccines
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents