Immunomodulatory Drugs + Corticosteroid for Multiple Myeloma

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of combining immunomodulatory drugs, which help the immune system, with the corticosteroid dexamethasone in treating multiple myeloma and smoldering multiple myeloma. The study aims to determine which drug combinations are most effective for these conditions. Individuals diagnosed with multiple myeloma—whether newly diagnosed, with a previous relapse, or showing early signs (smoldering)—and who have experienced frequent symptoms or past treatments might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.

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

Research shows that treatments combining drugs like lenalidomide and pomalidomide with dexamethasone (a strong anti-inflammatory) are generally well-tolerated by patients with multiple myeloma. Studies have found that lenalidomide and dexamethasone together can lead to better results and longer survival compared to dexamethasone alone. However, this combination carries risks, such as a higher chance of heart attacks and strokes.

For pomalidomide with dexamethasone, research indicates this combination is safe and effective for patients whose myeloma has returned after treatment. Most side effects can be managed and are expected, but some can be serious and require close monitoring.

These drugs have FDA approval for treating multiple myeloma, indicating well-known safety profiles, though individual reactions may vary. Always consult a healthcare provider about potential risks before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for multiple myeloma because they integrate both immunomodulatory drugs, like lenalidomide and pomalidomide, and a corticosteroid, dexamethasone, to potentially enhance the body's immune response against cancer cells. Unlike the standard treatment options, which often rely on a single approach, this combination therapy aims to tackle the disease from multiple angles, potentially increasing its effectiveness. Specifically, pomalidomide is known for its strong immune-stimulating properties, which may offer an advantage over traditional therapies. This multifaceted strategy could lead to better outcomes for patients, especially those with relapsed or refractory multiple myeloma.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that lenalidomide combined with dexamethasone effectively treats multiple myeloma. One study found that 31 out of 34 patients responded well to this treatment, with some experiencing a complete or very good partial recovery. In this trial, some participants will receive lenalidomide and dexamethasone, while others will receive pomalidomide and dexamethasone. Studies indicate that pomalidomide and dexamethasone serve as a standard treatment for recurrent multiple myeloma. Specifically, patients treated with pomalidomide lived longer than those who only received high-dose dexamethasone; one study showed an increase in survival by about 4.6 months. Both treatments help manage the disease and improve outcomes for patients with multiple myeloma. ^{5 6 7 8 9}

Who Is on the Research Team?

Wilson Gonsalves, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0147027224000199

An analysis of real-world electronic health records data This retrospective longitudinal study compared the effectiveness of dexamethasone+lenalidomide (Rd)-based triplet regimens containing proteasome inhibitors ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2503648/

A review of lenalidomide in combination with ... Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38547609/

An analysis of real-world electronic health records data Comparative effectiveness of lenalidomide/dexamethasone-based triplet regimens for treatment of relapsed and/or refractory multiple myeloma ...

4. ashpublications.org ashpublications.org/blood/article/145/1/75/517990/Dexamethasone-dose-intensity-does-not-impact

Dexamethasone dose intensity does not impact outcomes in ... Our study suggests that dexamethasone dose reductions are common in multiple myeloma, even within clinical trials. Given the many toxicities and ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa070596

Lenalidomide plus Dexamethasone for Relapsed Multiple ... As of May 2006, a total of 49 patients (27.7%) had died in the lenalidomide group (40 from progressive disease), as had 63 patients (35.8%) in the placebo group ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2728892/

Expanded safety experience with lenalidomide plus ... Primary cause of death was disease progression (10%). Safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in patients with relapsed/ ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-cancer-drug-revlimid-lenalidomide-and-risk

Safety review update of cancer drug Revlimid Know that, in clinical trials of patients newly diagnosed with multiple myeloma, those patients treated with Revlimid had an increased risk of ...

8. myeloma.org myeloma.org/revlimid-lenalidomide

Revlimid (Lenalidomide) The risk is even higher for people with multiple myeloma who take dexamethasone with Revlimid. Heart attacks and strokes are also more frequent in people who ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3256976/

Safety and Efficacy of Lenalidomide in Relapsed or ... Combination lenalidomide and dexamethasone (Len+Dex) has been shown to increase response rates and prolong survival compared with dexamethasone alone.