Immunomodulatory Drugs + Corticosteroid for Multiple Myeloma

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Immunomodulatory drugs

Must not be taking: Antiretrovirals

Disqualifiers: Pregnancy, HIV, Heart failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days for cycle 1, up to 5 cycles of 28 days

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of immunomodulatory drug(s) in combination with a corticosteroid drug in treating patients with multiple myeloma or smoldering multiple myeloma. Immunomodulatory drugs such as lenalidomide and pomalidomide work through a variety of mechanisms to affect the function of the immune system. They are widely used as treatment for multiple myeloma and remain the backbone of therapy for both newly diagnosed patients and patients that have multiple myeloma that has come back after treatment (relapsed). Corticosteroid drugs like dexamethasone are strong anti-inflammatory agents that are also widely used to treat patients with multiple myeloma. This study may help doctors find out how patients respond to one treatment cycle of immunomodulatory drug(s) in combination with dexamethasone. This may help doctors determine which combinations of drugs work best in treating patients with multiple myeloma or smoldering multiple myeloma.

Research Team

Wilson Gonsalves, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults with multiple myeloma, either untreated smoldering, newly diagnosed needing treatment, or relapsed/refractory after specific therapies. Participants must meet certain health criteria like blood counts and liver function, be willing to provide samples for research, follow REMS program requirements if on Pomalyst, and not be pregnant or nursing.

Inclusion Criteria

Your blood clotting time is within a certain range.

I have untreated smoldering multiple myeloma.

My kidneys are functioning well enough to clear waste.

Exclusion Criteria

You are taking any other experimental medication for your main type of cancer.

I had a heart attack less than 6 months ago.

I am immunocompromised or HIV positive and on antiretroviral therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immunomodulatory drugs (lenalidomide or pomalidomide) in combination with dexamethasone. Treatment for cycle 1 continues for 21 days, followed by up to 5 cycles of 28 days each.

21 days for cycle 1, up to 5 cycles of 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

1 week

Treatment Details

Interventions

• Dexamethasone
• Lenalidomide
• Pomalidomide

Trial Overview The study tests immunomodulatory drugs (Lenalidomide alone or with Pomalidomide) combined with a corticosteroid (Dexamethasone) in treating multiple myeloma. It aims to determine the best drug combinations by observing patient responses to one treatment cycle of these medications.

Participant Groups

Group I: Cohort D (lenalidomide, dexamethasone, pomalidomide) Experimental Treatment 4 Interventions

Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.

Group II: Cohort C (lenalidomide, dexamethasone, pomalidomide) Experimental Treatment 4 Interventions

Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Cohort B (lenalidomide, dexamethasone) Experimental Treatment 3 Interventions

Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.

Group IV: Cohort A (lenalidomide, dexamethasone) Experimental Treatment 3 Interventions

Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+