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Multiple MyelomaPhase 2NCT03376477

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

A Phase 2 study testing GM-CSF vaccine, Lenalidomide and Prevnar13 in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
GM-CSF vaccine, Lenalidomide and Prevnar13
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
23 Sep 2019to 30 May 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Myeloma eligibility criteria are the following:
  • Near complete remission (nCR) for ≥ 3 months defined as no measurable M-spike, and a positive serum immunofixation
  • For patients with a light chain only myeloma, they will be in deemed to be in a CR if they meet criteria for CR by International Myeloma Working Group (IMWG) consensus criteria 2016.
  • For patients with a light chain only myeloma that meet criteria for Very Good Partial Response (VGPR) by IMWG consensus criteria 2016 and are IFE -ve (negative serum immunofixation), they will be considered to be in a near complete remission (nCR).
  • 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
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  • 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
  • All patients must be MRD positive at 10-4 or greater by NGS sequencing at enrollment
  • All patients must be currently taking Revlimid at screening.
  • 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).

Who cannot join

  • 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 who are MRD negative by NGS at screening.
  • 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.;
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled Phase II Trial of an Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission

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).

Read the detailed description

This is a single institution, three- arm, randomized controlled, Phase II study examining the clinical efficacy of an allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide (with or without Prevnar) compared to lenalidomide and placebo (control arm).

Patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation), or complete remission (M-spike negative, negative immunofixation, and <5% clonal plasma cells on bone marrow) per criteria for response in a 3 month period. All patients must be minimal residual disease (MRD) positive by NGS sequencing at enrollment.

Prior to enrollment, patients will have been treated with a lenalidomide containing regimen for a minimum of 6 cycles. All patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.

Patients will be randomized to receive either an allogeneic myeloma vaccine and Prevnar vaccine in combination with lenalidomide, or allogeneic myeloma vaccine without Prevnar vaccine in combination with lenalidomide, or lenalidomide in combination with placebo. Patients will receive allogeneic myeloma vaccine or placebo injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter for up to 3 years. If assigned to allogeneic myeloma vaccine plus Prevnar vaccine arm, Prevnar-13 will be administered with each allogeneic myeloma vaccine. If assigned to either of the two arms that do not include Prevnar, then patients will receive a placebo in lieu of Prevnar on the same schedule. All patients will be followed for a minimum of 3 years.

Being tested
GM-CSF vaccine, Lenalidomide, Prevnar13, Placebo Prevnar13, Placebo GM-CSF Vaccine
Keywords
Lenalidomide, M-spike negative, GVax, GM-CSF secreting myeloma vaccine, MRD positive
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GM-CSF vaccineBiological

    Also called GVAX

    Each vaccination will consist of three total intra-dermal injections, on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months 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 injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each vaccination injection is approximately 0.7-0.8ml.

  • LenalidomideDrug

    Also called Revlimid

    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).

  • Prevnar13Drug

    Also called pneumococcal vaccine

    Prevnar will be administered at the same time points as the GM-CSF vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine.

  • Placebo Prevnar13Other

    Saline will be used for placebo. Placebo prevnar will be administered at the same time points as the GM-CSF vaccine or Placebo GM-CSF Vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine or placebo GM-CSF vaccine.

  • Placebo GM-CSF VaccineOther

    Saline will be used for placebo. Each placebo vaccine will consist of three total intra-dermal injections on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months 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. Placebo injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each injection is approximately 0.7-0.8ml.

Study groups in NCT03376477
Study groupRoleWhat they receive
Lenalidomide plus GM-CSF Vaccine plus Prevnar13ExperimentalPatients 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. Prevnar vaccine will be administered with the GM-CSF vaccine administration.
Receives: Biological: GM-CSF vaccine; Drug: Lenalidomide; Drug: Prevnar13
Lenalidomide OnlyPlacebo comparatorPatients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients will also get placebo GM-CSF vaccine and placebo prevnar13. Placebo will be saline.
Receives: Drug: Lenalidomide; Other: Placebo Prevnar13; Other: Placebo GM-CSF Vaccine
Lenalidomide plus GM-CSF VaccinePlacebo comparatorPatients 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. Patients will also be administered a placebo prevnar13 vaccination. Placebo will be saline.
Receives: Biological: GM-CSF vaccine; Drug: Lenalidomide; Other: Placebo Prevnar13

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year Progression Free Survival

    Number of participants without disease progression at 2 years.

    Measured: 2 years

Secondary outcomes (6)

  1. Response Conversion Rate

    Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.

    Measured: 2 years

  2. MRD Conversion Rate

    Number of participants who convert from MRD (Minimal Residual Disease) positive status to MRD negative status as determined through next generation sequencing (NGS).

    Measured: 2 years

  3. Time to Response

    Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells as measured by immunofixation converting from positive to negative.

    Measured: 2 Years

  4. Progression Free Survival (PFS)

    Number of months without disease progression.

    Measured: 3 and 5 years

  5. Evaluate Toxicity of Allogenic Myeloma Vaccine

    Number of participants experiencing adverse events grade 3 or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

    Measured: 3 years

  6. Measure Tumor Specific Immunity and Correlate With Systemic Immunity

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start23 Sep 2019
  3. Primary completion2 Jan 2024
  4. Study completion30 May 2025

Why it stopped: loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All patients will continue on a standard dose of lenalidomide. Patients on the myeloma vaccine arm will receive injections in addition to lenalidomide unless otherwise clinically indicated, or until progression. Patients on myeloma plus Prevnar vaccine arm will receive injections of both allogenic myeloma vaccine and Prevnar vaccine in addition to lenalidomide unless otherwise clinically indicated, or until progression. Patients on the myeloma vaccine placebo arm will receive myeloma vaccine placebo on the same schedule as allogeneic myeloma vaccine. If assigned to either of the two arms that do not include Prevnar, then patients will receive placebo in lieu of Prevnar on the same schedule. The placebo will be saline. All patients will be followed for a minimum of 3 years.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376477
Sponsor's protocol ID
J16118
Other IDs
IRB00112179
Status last verified
Aug 2025
First submitted
30 Nov 2017
Last updated
27 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GM-CSF vaccine, Lenalidomide and Prevnar13 in people with Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03376477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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