Cancer Vaccine Combo for Multiple Myeloma

Not currently recruiting at 6 trial locations

Overseen By Noopur Raje, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants, HDAC inhibitors

Disqualifiers: Symptomatic MM, Prior malignancy, Cardiac issues, Auto-immune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of treatments to determine their effectiveness for individuals with Smoldering Multiple Myeloma, a condition that can progress to a more aggressive blood cancer. The study includes three treatments: Lenalidomide (Revlimid), Citarinostat, and PVX-410 (a cancer vaccine), administered in various combinations to identify the most effective approach. The goal is to assess whether these treatments can slow or prevent disease progression. Suitable candidates for this trial have a confirmed diagnosis of Smoldering Multiple Myeloma and are at higher risk of developing active multiple myeloma based on specific health markers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these innovative therapies.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using immunosuppressive medication within 28 days before the first dose, except for certain low-dose corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of PVX-410, citarinostat, and lenalidomide is generally safe for people with Smoldering Multiple Myeloma. One study found that patients tolerate this combination well. Lenalidomide, already approved by the FDA for treating this condition, adds confidence in its safety.

The PVX-410 vaccine, whether used alone or with lenalidomide, has demonstrated safety and effectiveness in triggering an immune response in patients. This supports further research into this treatment for multiple myeloma. Additionally, early trials found that the combination of PVX-410 and citarinostat is safe, indicating good patient tolerance.

Overall, these findings suggest that the treatments in this trial have maintained a good safety record so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment combination of PVX-410, Citarinostat, and Lenalidomide for multiple myeloma because it targets the cancer in a unique way. Unlike traditional treatments like chemotherapy, this combo includes a cancer vaccine (PVX-410) that aims to train the immune system to recognize and attack multiple myeloma cells. Citarinostat adds another layer by inhibiting enzymes that regulate gene expression, potentially making cancer cells more vulnerable to attack. The addition of Lenalidomide, a drug that modulates the immune system and inhibits cancer cell growth, rounds out a multi-faceted approach that could offer more effective results than existing treatments alone.

What evidence suggests that this trial's treatments could be effective for Smoldering Multiple Myeloma?

Studies have shown that the PVX-410 vaccine, combined with citarinostat, can help the immune system combat cancer in patients with smoldering multiple myeloma. This combination is generally safe and aims to enhance the body's ability to attack cancer cells. In this trial, some participants will receive this combination, while others will also receive lenalidomide, which might further boost the immune response. Research suggests that these treatments may be more effective when used together to target cancer cells. Early results appear promising, but more information is needed to fully understand their effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Noopur Raje, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with Smoldering Multiple Myeloma (SMM) who have a high risk of the disease progressing. Participants must have normal organ and marrow function, no history of symptomatic MM or other malignancies in the past 3 years, no severe heart conditions, infections or autoimmune diseases. They should not be on immunosuppressive medications recently and must agree to use birth control if applicable.

Inclusion Criteria

I am HLA-A2 positive.

Patient is willing and able to comply with the protocol for the duration of the study

Patient meets the CRAB criteria within 4 weeks before baseline

Exclusion Criteria

I have been previously diagnosed with tuberculosis.

I currently have an active infection or tested positive for certain viruses.

I have used immunosuppressive medication within the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 biweekly doses of PVX-410 and Hiltonol, and 3 monthly cycles of Citarinostat, with or without Lenalidomide

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Citarinostat
• Lenalidomide
• PVX-410

Trial Overview The study tests a cancer vaccine called PVX-410 and two drugs: Citarinostat and Lenalidomide as potential treatments for SMM. The goal is to see if these interventions can prevent SMM from becoming more aggressive. Some participants may receive all three treatments while others might get only one or two.

How Is the Trial Designed?

Group I: PVX-410 + Citarinostat + Lenalidomide Experimental Treatment 4 Interventions

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat * 3 monthly cycles of Lenalidomide

Group II: PVX-410 + Citarinostat Experimental Treatment 3 Interventions

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

OncoPep, Inc.

Industry Sponsor

Trials

4

Recruited

120+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02886065

A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- ... This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma.

2. nature.com nature.com/articles/s41408-025-01272-2

Immune profiling of smoldering multiple myeloma patients ... We investigated whether the PVX-410 vaccine, combined with citarinostat (an HDACi), with or without lenalidomide, enhances anti-cancer immune responses in SMM.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123086202

Poster Abstracts 653.Multiple Myeloma The combination of PVX-410 with citarinostat, with and without lenalidomide is generally safe in this patient population. The objective clinical response was ...

4. healthtree.org healthtree.org/myeloma/community/articles/clinical-trial-using-a-vaccine-pvx-410-with-citarinostat-lenalidomide-for-smoldering-multiple-myeloma

Clinical Trial: Using a Vaccine PVX-410 with Citarinostat + A new clinical trial is open for myeloma patients who have moderate to high risk smoldering multiple myeloma using a cancer vaccine.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30128502/

Assessment of Safety and Immunogenicity of PVX-410 ... Overall, these results suggest that the vaccine is safe and immunogenic in this patient population and support continued study of PVX-410 in SMM.

6. biospace.com biospace.com/oncopep-announces-a-phase-1b-clinical-trial-of-its-multi-peptide-cancer-vaccine-pvx-410-in-combination-with-citarinostat-for-smoldering-multiple-myeloma

OncoPep Announces a Phase 1b Clinical Trial of Its Multi ... “This Phase 1b clinical trial will further evaluate the safety and tolerability of PVX-410 in combination with the HDAC 6 inhibitor, ...