Clinical Trials /

Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission

NCT03376477

Description:

This study seeks to determine whether addition of an allogeneic myeloma vaccine can augment clinical responses to lenalidomide in patients with near complete remission (nCR), or complete remission (CR) leading to a significant improvement in progression-free survival.This main objective of this study is to compare the 2-year progression free survival of patients with multiple myeloma in CR or nCR, treated with lenalidomide plus an allogeneic myeloma vaccine in combination with lenalidomide (with or without Prevnar vaccine) or versus placebo in combination with lenalidomide (control arm).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide Compared to Lenalidomide Alone in Multiple Myeloma Patients
  • 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

Clinical Trial IDs

  • ORG STUDY ID: J16118
  • SECONDARY ID: IRB00112179
  • NCT ID: NCT03376477

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
GM-CSF vaccineLenalidomide plus GM-CSF Vaccine
LenalidomideLenalidomide plus GM-CSF Vaccine

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Lenalidomide plus GM-CSF VaccineExperimentalPatients 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.
  • GM-CSF vaccine
  • Lenalidomide
Lenalidomide OnlyActive ComparatorPatients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment
  • Lenalidomide

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:2-year progression free survival
Time Frame:2 years
Safety Issue:
Description:To compare the 2-year progression free survival of patients treated with lenalidomide alone or in combination with vaccine.

Secondary Outcome Measures

Measure:CR Conversion Rate
Time Frame:3 years
Safety Issue:
Description:Determine the rate of conversion from near CR (immunofixation positive) to true CR (immunofixation negative)
Measure:MRD Conversion Rate
Time Frame:3 years
Safety Issue:
Description:Determine the rate of conversion from MRD (Minimal Residual Disease) positive status to MRD negative status by NGS (next generation sequencing).
Measure:Time to Response
Time Frame:3 Years
Safety Issue:
Description:
Measure:Progression Free Survival
Time Frame:3 and 5 years
Safety Issue:
Description:Determine progression free survival at 3 and 5 years.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Lenalidomide
  • M-spike negative
  • GVax
  • GM-CSF secreting myeloma vaccine

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