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Lenalidomide for Multiple Myeloma

Phase 3
Waitlist Available
Led By Philip L McCarthy
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
No prior progression after initial therapy; in addition, no more than two regimens will be allowed excluding dexamethasone alone
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (up to 10years)
Awards & highlights

Study Summary

This trial compares lenalidomide to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant.

Who is the study for?
This trial is for patients with active multiple myeloma who need treatment and have responded to at least 2 months of induction therapy. They should not have had more than 12 months of prior treatments, no previous transplants, and must be able to collect enough stem cells for the procedure. Participants need good heart and lung function, controlled diabetes if present, no serious infections or HIV/Hepatitis B/C. Women of childbearing age must test negative for pregnancy and use two forms of birth control.Check my eligibility
What is being tested?
The study tests whether lenalidomide improves outcomes in multiple myeloma patients after an autologous stem cell transplant compared to a placebo. Patients receive chemotherapy followed by their own previously collected stem cells to restore bone marrow function. Lenalidomide aims to boost the immune system against cancer cells post-transplant.See study design
What are the potential side effects?
Lenalidomide may cause blood disorders (like low white blood cell counts), fatigue, digestive issues (such as diarrhea or constipation), rash or itching, muscle cramps, and increased risk of infection or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not worsen after my first treatment, and I've had no more than two treatment plans.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lungs work well enough to breathe without symptoms.
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My multiple myeloma is active and needs treatment, and I've responded to initial therapy.
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I started my first cancer treatment less than a year ago.
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I am not pregnant or nursing and will follow strict birth control measures if of childbearing age.
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I have collected the required number of stem cells for my treatment.
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I have not had any blood, bone marrow, or organ transplant.
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I do not have any serious infections right now.
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My heart pumps well, with an ejection fraction of 40% or higher.
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I have had less than a year of treatment, including specific medications.
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My diabetes is under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study (up to 10years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (up to 10years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Progression
Secondary outcome measures
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Other outcome measures
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (melphalan, autologous PBSCT, lenalidomide)Experimental Treatment5 Interventions
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (melphalan, autologous PBSCT, placebo)Placebo Group5 Interventions
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Melphalan
2008
Completed Phase 3
~1500
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,186 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,525 Patients Enrolled for Multiple Myeloma
Philip L McCarthyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Autologous Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT00114101 — Phase 3
Multiple Myeloma Research Study Groups: Arm II (melphalan, autologous PBSCT, placebo), Arm I (melphalan, autologous PBSCT, lenalidomide)
Multiple Myeloma Clinical Trial 2023: Autologous Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT00114101 — Phase 3
Autologous Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT00114101 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being accepted into this research study?

"This particular clinical trial is open to patients that are aged between 18-70."

Answered by AI

For what illnesses is Autologous Hematopoietic Stem Cell Transplantation most often the go-to treatment?

"Autologous Hematopoietic Stem Cell Transplantation is most commonly used for treatment of chronic lymphocytic leukemia. However, it can also be used as a form of treatment for stage i mycosis fungoides, at least two prior systemic chemotherapy regimens, polycythemia vera (pv)."

Answered by AI

Are there any specific types of people who should not sign up for this trial?

"This study is meant for stage i plasma cell myeloma patients between 18 and 70 years old. They are looking for around 460 individuals in total."

Answered by AI

Are there different hospitals in this city participating in this research project?

"Presently, this clinical trial is running in 100 locations, some notable ones being Havana, Minneapolis and Peoria. If you're considering participating in this trial, know that it might be most convenient for you to select a location that is close to where you live."

Answered by AI

Could you please summarize the Autologous Hematopoietic Stem Cell Transplantation research that has been conducted thus far?

"City of Hope Comprehensive Cancer Center was the first to study Autologous Hematopoietic Stem Cell Transplantation in 1997. Since the initial study, there have been 1124 completed clinical trials. Currently, there are 408 clinical trials recruiting patients, many of which are based in Havana, Illinois."

Answered by AI

Does the FDA recognize Autologous Hematopoietic Stem Cell Transplantation as a viable treatment?

"Autologous hematopoietic stem cell transplantation has some efficacy data from Phase 3 trials and thus our team rates it as a 3 in terms of safety."

Answered by AI

Are researchers still recruiting participants for this experiment?

"The listing for this clinical trial on clinicaltrials.gov indicates that the research team is not presently recruiting patients. Although, this may be due to the fact that the trial was first posted on December 15th, 2004 and was last updated on July 27th, 2022. There are 1235 other studies that are actively recruiting patients."

Answered by AI
~23 spots leftby Mar 2025