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

NCT03376477 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: J16118IRB00112179
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Multiple Myeloma

Keywords

Lenalidomide; M-spike negative; GVax; GM-CSF secreting myeloma vaccine; MRD positive

Outcome Measures

Primary Outcomes (1)

• 2-year Progression Free Survival

  Number of participants without disease progression at 2 years.

  2 years

Secondary Outcomes (6)

• Response Conversion Rate

  2 years

• MRD Conversion Rate

  2 years

• Time to Response

  2 Years

• Progression Free Survival (PFS)

  3 and 5 years

• Evaluate Toxicity of Allogenic Myeloma Vaccine

  3 years

Study Arms (3)

Lenalidomide plus GM-CSF Vaccine plus Prevnar13

EXPERIMENTAL

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. Prevnar vaccine will be administered with the GM-CSF vaccine administration.

Biological: GM-CSF vaccine; Drug: Lenalidomide; Drug: Prevnar13

Lenalidomide Only

PLACEBO COMPARATOR

Patients 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.

Drug: Lenalidomide; Other: Placebo Prevnar13; Other: Placebo GM-CSF Vaccine

Lenalidomide plus GM-CSF Vaccine

PLACEBO COMPARATOR

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. Patients will also be administered a placebo prevnar13 vaccination. Placebo will be saline.

Biological: GM-CSF vaccine; Drug: Lenalidomide; Other: Placebo Prevnar13

Interventions

GM-CSF vaccine BIOLOGICAL

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.

Also known as: GVAX

Lenalidomide plus GM-CSF Vaccine; Lenalidomide plus GM-CSF Vaccine plus Prevnar13

Lenalidomide DRUG

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).

Also known as: Revlimid

Lenalidomide Only; Lenalidomide plus GM-CSF Vaccine; Lenalidomide plus GM-CSF Vaccine plus Prevnar13

Prevnar13 DRUG

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.

Also known as: pneumococcal vaccine

Lenalidomide plus GM-CSF Vaccine plus Prevnar13

Placebo Prevnar13 OTHER

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.

Lenalidomide Only; Lenalidomide plus GM-CSF Vaccine

Placebo GM-CSF Vaccine OTHER

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.

Lenalidomide Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.;
• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Celgene: collaborator
• Aduro Biotech, Inc.: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Recruitment was significantly negatively impacted by COVID pandemic

Results Point of Contact

• Title: Syed Abbas Ali, MD- Assistant Professor- Division of Hematologic Malignancies
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

sali35@jhmi.edu

4432877104

Study Officials

• Syed A Ali, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 18, 2017
• Study Start: September 23, 2019
• Primary Completion: January 2, 2024
• Study Completion: May 30, 2025
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)