Immunotherapy for Smoldering Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen by Elisabet E Manasanch, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This pilot early phase I trial studies pembrolizumab in treating patients with slow growing (smoldering) multiple myeloma with intermediate or high-risk of spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

Adults with intermediate or high-risk smoldering multiple myeloma who meet specific diagnostic criteria, have good kidney function and general health, and can give informed consent. They must not have active autoimmune diseases, other cancers, severe lung conditions, infections needing systemic therapy, or a history of certain immune disorders.

Inclusion Criteria

Adults with a certain type of smoldering multiple myeloma that is at intermediate or high risk.

Your SMM diagnosis is confirmed by specific medical criteria from the Mayo clinic, PETHEMA, or SWOG.

Your kidneys work well enough to filter out waste from your blood.

Exclusion Criteria

You have had a serious autoimmune disease that needed strong medication in the last 2 years.

You have another cancer that is currently getting worse or is still active.

You have a history of needing steroids for lung inflammation or currently have lung inflammation.

Participant Groups

The trial is testing pembrolizumab's effectiveness for patients with slow-growing multiple myeloma at risk of spreading. It's an early phase study to see how well the body's immune system can fight cancer when helped by this monoclonal antibody drug.

Group I: Treatment (pembrolizumab) Experimental Treatment 2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇪🇺 Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇬🇧 Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References