What is the mechanism of action of this treatment?

The most common treatments for Multiple Myeloma include lenalidomide, thalidomide, and dexamethasone. Lenalidomide and thalidomide are immunomodulatory drugs that stimulate the immune system and inhibit cancer cell growth by blocking blood flow to the cancer. Dexamethasone is a corticosteroid that kills cancer cells and reduces inflammation. These mechanisms are important for Multiple Myeloma patients as they help in selecting effective treatment regimens, managing side effects, and improving overall treatment outcomes.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as lenalidomide, thalidomide, and dexamethasone, are associated with a range of side effects. Lenalidomide and thalidomide can cause immunomodulatory effects, leading to increased risks of infections, including upper respiratory tract infections and pneumonia. Other side effects include diarrhea, constipation, fatigue, and peripheral neuropathy. Dexamethasone, a corticosteroid, can cause hyperglycemia, insomnia, and increased risk of infections. Bortezomib and carfilzomib, proteasome inhibitors often used in combination with lenalidomide, can lead to peripheral neuropathy, gastrointestinal issues, and increased risk of serious infections, particularly in the lower respiratory tract.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma that are similar to lenalidomide, which stimulates the immune system and inhibits cancer cell growth by blocking blood flow. Thalidomide was one of the first immunomodulatory drugs approved for this purpose. Lenalidomide, a more potent derivative, has been approved for use both as a single agent and in combination with dexamethasone. Pomalidomide, another related drug, is also approved for patients who have relapsed after prior therapies. These drugs are often used in combination with dexamethasone, a corticosteroid that helps reduce inflammation and kill cancer cells.

What other types of research exist?

Promising alternatives to Lenalidomide for Multiple Myeloma patients include: 1) Carfilzomib, a proteasome inhibitor that has shown efficacy in combination with dexamethasone. 2) Daratumumab, an anti-CD38 monoclonal antibody, which has demonstrated significant activity in MM. 3) Isatuximab, another anti-CD38 monoclonal antibody, effective in relapsed/refractory MM. 4) Venetoclax, a BCL-2 inhibitor, particularly for patients with t(11;14) translocation. 5) Elotuzumab, an anti-SLAMF7 monoclonal antibody, used in combination with lenalidomide and dexamethasone.

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Corticosteroid

Lenalidomide + Dexamethasone +/- Thalidomide for Multiple Myeloma

Phase 3

Waitlist Available

Led By S. V Rajkumar

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Must have specified renal and hepatic function within defined limits

Must not have

Must not have uncontrolled intercurrent illness including specific conditions

Must not have a history of current or previous deep vein thrombosis or pulmonary embolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 4 weeks for 16 weeks during step 2

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests if lenalidomide with either standard or low-dose dexamethasone works better for new multiple myeloma patients. If not, thalidomide is added. The goal is to find effective treatments with fewer side effects. Lenalidomide plus low-dose dexamethasone has been shown to be an effective treatment for multiple myeloma, particularly in patients who are not candidates for stem cell transplantation.

Who is the study for?

This trial is for adults recently diagnosed with symptomatic multiple myeloma. They should have certain blood and marrow conditions, not be pregnant or breastfeeding, and can't have had previous systemic therapy for the disease (except bisphosphonates). People with severe illnesses, uncontrolled infections, a history of blood clots without anticoagulation therapy, or significant neuropathy cannot join.

What is being tested?

The study compares lenalidomide combined with low or standard doses of dexamethasone against the same regimen plus thalidomide in treating multiple myeloma. It aims to see which combination is more effective at stopping cancer growth by affecting the immune system and cutting off cancer's blood supply.

What are the potential side effects?

Potential side effects include risk of infection, blood clots, nerve damage (neuropathy), fatigue, constipation, rash and may affect liver function. Thalidomide specifically can cause birth defects; hence strict contraception measures are required.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My kidney and liver functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses that are not under control.

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I have never had deep vein thrombosis or a pulmonary embolism.

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I do not have severe numbness or pain in my hands or feet.

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I do not have uncontrolled seizures.

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I do not have smoldering myeloma or MGUS.

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I have not taken steroids for multiple myeloma.

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I am not pregnant or breastfeeding.

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I do not have any ongoing, untreated infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 4 weeks for 16 weeks during step 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 4 weeks for 16 weeks during step 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 4 weeks for 16 weeks during step 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Patients With Objective Response (First Phase, Step 1)

Secondary study objectives

Proportion of Patients With Objective Response (First Phase, Step 2)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IV (thalidomide, low-dose dexamethasone)Experimental Treatment3 Interventions

Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Group II: Arm II (lenalidomide, low-dose dexamethasone)Experimental Treatment3 Interventions

Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Group III: Arm III (thalidomide, dexamethasone)Active Control3 Interventions

Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20

Group IV: Arm I (lenalidomide, dexamethasone)Active Control3 Interventions

Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thalidomide

2001

Completed Phase 4

~3050

Dexamethasone

2007

Completed Phase 4

~2650

Lenalidomide

2005

Completed Phase 3

~2240

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include lenalidomide, thalidomide, and dexamethasone. Lenalidomide and thalidomide are immunomodulatory drugs that stimulate the immune system and inhibit cancer cell growth by blocking blood flow to the cancer. Dexamethasone is a corticosteroid that kills cancer cells and reduces inflammation. These mechanisms are important for Multiple Myeloma patients as they help in selecting effective treatment regimens, managing side effects, and improving overall treatment outcomes.

Expanding role of lenalidomide in hematologic malignancies.