Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple Myeloma

NCT03782064 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-280
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a cancer vaccine called Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) in combination with nivolumab, as a possible treatment for multiple myeloma (MM). The drugs involved in this study are:

• Dendritic Cell/MM Fusion vaccine (DC/MM vaccine)
• Nivolumab, an immunotherapy drug

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Develop Immunologic Response to Nivolumab and the DC/MM Fusion Vaccine

  We planned to evaluate the immunologic response to treatment in blood and bone marrow. Two patients were treated on protocol and both came off due to disease progression early in the course of therapy (one patient during cycle 1 and one patient during cycle 3.) As such, there is insufficient data to perform what had been planned in correlative science studies so no samples were analyzed. This study has been stopped and no further patients are being enrolled and no further samples are being collected. No data has been obtained for any immune analysis; therefore no immune or clinical data will be reported on this trial.

  2 years

Secondary Outcomes (3)

• Number of Patients Who Achieve a Clinical Response (SD, PR, VGPR, CR)

  2 years

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  2 years

• Number of Patients Who Are Alive Without Progression at 2 Years

  2 years

Study Arms (1)

Nivolumab+DC/myeloma fusions/GM-CSF

EXPERIMENTAL

* Nivolumab will be given every two weeks * The DC/myeloma fusion vaccine/GM-CSF is administered 4 days per cycle

Drug: Nivolumab; Biological: DC/myeloma fusions/GM-CSF

Interventions

Nivolumab DRUG

Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.

Nivolumab+DC/myeloma fusions/GM-CSF

DC/myeloma fusions/GM-CSF BIOLOGICAL

The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.

Nivolumab+DC/myeloma fusions/GM-CSF

Eligibility Criteria

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

You may qualify if:

• Patients must have Patients with relapsed multiple myeloma with prior treatment of an IMID and proteasome inhibitor.
• Age ≥18 years.
• ECOG performance status ≤2
• Patients must have \> 20% plasma cells in the bone marrow aspirate differential \<30 days prior to enrollment.
• ANC \> 1000; Platelets \> 75K without transfusional support
• Participants must have normal organ function as defined below:
• total bilirubin ≤1.5 × institutional upper limit of normal
• AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal
• creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• The effects of DC/MM fusion and nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 5 months after completion of treatment.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Participants who are receiving any other investigational agents.
• Patients with purely non-secretory MM \[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence-Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain \>100 mg/L\]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
• Patients with Plasma Cell Leukemia
• Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
• Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
• Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:
• GI Disorders: (including inflammatory bowel disease \[e.g. ulcerative colitis, Crohn's disease\], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.
• Systemic lupus erythematosus
• Wegener's syndrome \[granulomatosis with polyangiitis\]
• Myasthenia gravis
• Graves' disease
• Rheumatoid arthritis
• Hypophysitis
• Uveitis
• The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Bristol-Myers Squibb: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Nivolumab

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to withdrawal of funding, this study was halted prematurely. Only two participants were treated and we were unable to analyze the data in any meaningful way due to the small sample size.

Results Point of Contact

• Title: Emma Logan, Director of Research Nursing
• Organization: Beth Israel Deaconess Medical Center

eklogan@bidmc.harvard.edu

6176675984

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 20, 2018
• Study Start: February 22, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: June 22, 2023
• Results First Posted: September 1, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)