Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
NCT ID: NCT01793051
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2013-03-22
2020-09-18
Brief Summary
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Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine production, which may help to reduce multiple symptoms.
Detailed Description
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If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
Group 1 will take a placebo during maintenance therapy.
Group 2 will take minocycline during maintenance therapy.
A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what they are receiving.
Study Drug Administration:
Participant will take the study drug/placebo by mouth, two times a day for about 3 months, starting the first day (or within 2 days) that they begin their lenalidomide therapy.
Participant should take the study drug/placebo with a full glass (8 ounces) of water. Participant may take it with or without food, but if the study drug/placebo causes an upset stomach, participant should take it with food.
Study Visits:
Participant must bring the study drug/placebo container, along with any remaining drug, with them to their clinic visit at each new cycle of lenalidomide therapy, or at the clinic visit when the study is over if no clinic visits are scheduled until then.
Before participant starts lenalidomide therapy:
* Participant will fill out 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires.
* A study staff member will ask participant questions about their demographic information, such as their marital status, job status, education, and race.
* Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick. Biomarkers are found in the blood/tissue and may be related to participant's reaction to the study drug. Researchers want to study how changes in the biomarkers may be related to the symptoms reported by participants in this study.
During lenalidomide therapy:
°Participant will complete a symptom questionnaire in the clinic or by telephone 1 time each week about any symptoms they may be having and how they may be affecting participant's daily activities. The symptom questionnaire should take about 3-5 minutes to complete each time.
During participant's clinic visit at each new cycle of lenalidomide therapy:
* Participant will fill out 3 questionnaires about their pain and other symptoms. It should take about 15-20 minutes to complete all of the questionnaires each time. If no clinic visit is scheduled until the study is over, these questionnaires will be collected over the phone by the study coordinator.
* Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick.
End-of-Treatment Visit:
Participant will have an end-of-treatment visit at the end of month 3. At this visit, participant will complete 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires. Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick.
Length of Study:
Participant may continue taking the study drug/placebo for up to 3 months. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if they are unable to follow study directions, or the study doctor thinks it is in their best interest.
This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The use of minocycline to reduce chemotherapy related side effects in patients with MM is currently being used for research purposes only.
Up to 88 participants will take part in this study. All will be enrolled at MD Anderson Cancer Center.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Minocycline
Minocycline 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance chemotherapy for MM.
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Minocycline
200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance therapy for MM.
Questionnaires
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Placebo
Placebo 200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Placebo
200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).
Questionnaires
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Interventions
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Minocycline
200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance therapy for MM.
Placebo
200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).
Questionnaires
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients \> or = 18 years old.
3. Patients able to render informed consent and to follow protocol requirements.
4. Patients who speak English (due to patient-reported outcome language options, we are only accruing English-speaking patients to the protocol).
5. Patients with normal renal function according to MD Anderson testing standards and no prior renal disease \[screening cut off for serum creatinine \< 1.5 times the upper limit of normal\].
6. Patients with normal hepatic function according to MD Anderson testing standards and no prior liver disease \[screening results for total bilirubin must be \< 1.5 times the upper limit of normal; screening results for alkaline phosphatase (ALP) and alanine aminotransferase (ALT) must be \< 2 times the upper limit of normal; if available, screening results for aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal\].
Exclusion Criteria
2. Patients with hypersensitivity to tetracyclines
3. Women who are pregnant or nursing; pregnancy will be confirmed by urine test
4. Patients who are enrolled in other clinical trials that have symptom management as primary outcome
5. Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)
6. Patients taking any tetracycline in the last 15 days
7. Patients on Vitamin K antagonist warfarin
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Robert Orlowski, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2013-00700
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0413
Identifier Type: -
Identifier Source: org_study_id