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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

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 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)

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
~1340

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,385 Total Patients Enrolled
590 Trials studying Multiple Myeloma
188,903 Patients Enrolled for Multiple Myeloma
S. V RajkumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Multiple Myeloma Research Study Groups: Arm IV (thalidomide, low-dose dexamethasone), Arm II (lenalidomide, low-dose dexamethasone), Arm III (thalidomide, dexamethasone), Arm I (lenalidomide, dexamethasone)
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT00098475 — Phase 3
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00098475 — Phase 3
~22 spots leftby Oct 2025