NCT01995708

Brief Summary

The purpose of this study is to see if the investigator can help the immune system to work against myeloma. This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 9, 2024

Completed
Last Updated

February 9, 2024

Status Verified

June 1, 2022

Enrollment Period

8.4 years

First QC Date

November 20, 2013

Results QC Date

June 9, 2023

Last Update Submit

June 9, 2023

Conditions

Multiple Myeloma

Keywords

CT7MAGE-A3WT1 mRNA-electroporated Autologous LangerhansvaccineAutologous Stem Cell Transplantation13-009

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Evaluated for Vaccine Safety

    Participants will be evaluated for the safety of the vaccine, monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity. The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.

    1 year

Secondary Outcomes (1)

  • Median Progression Free Survival

    Up to 7 years

Study Arms (2)

Arm 1 Vaccine

EXPERIMENTAL

This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical \& Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10\^6 LCs per dose (i.e., combination of 3x10\^6 CT7 mRNA-electroporated LCs + 3x10\^6 MAGE-A3 mRNA-electroporated LCs + 3x10\^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression.

Biological: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)

Arm 2 control

ACTIVE COMPARATOR

Patients receive standard of care treatment after autologous stem cell transplant

Other: Standard of care

Interventions

CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)BIOLOGICAL

Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\^6 LCs per vaccine x 3.

Arm 1 Vaccine
Standard of careOTHER

No vaccines

Arm 2 control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
  • Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
  • Deemed eligible for ASCT by standard institutional criteria.
  • Age ≥18 years.
  • Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.

You may not qualify if:

  • Prior autologous or allogeneic SCT.
  • Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.
  • Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
  • History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
  • History of severe allergic reactions to vaccines or unknown allergens.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
  • Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Chung DJ, Sharma S, Rangesa M, DeWolf S, Elhanati Y, Perica K, Young JW. Langerhans dendritic cell vaccine bearing mRNA-encoded tumor antigens induces antimyeloma immunity after autotransplant. Blood Adv. 2022 Mar 8;6(5):1547-1558. doi: 10.1182/bloodadvances.2021005941.

    PMID: 35100339DERIVED

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

MAGEC1 protein, humanMAGEA3 protein, humanStandard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. David Chung, MD, PhD
Organization
Memorial Sloan Kettering Cancer Center
ChungD1@MSKCC.ORG
646-608-3770

Study Officials

  • David Chung, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

January 31, 2014

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

February 9, 2024

Results First Posted

February 9, 2024

Record last verified: 2022-06

Locations

US(1)