Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01793051 |
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Recruitment Status :
Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : November 24, 2017
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The goal of this clinical research study is to learn if minocycline can help reduce the symptoms reported by patients with MM who receive therapy with lenalidomide.
Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine production, which may help to reduce multiple symptoms.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myeloma | Drug: Minocycline Other: Placebo Behavioral: Questionnaires | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma |
| Actual Study Start Date : | March 2013 |
| Estimated Primary Completion Date : | March 2019 |
| Estimated Study Completion Date : | March 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
Drug: 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.
Other Names:
Behavioral: Questionnaires Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Names:
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Placebo Comparator: 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. |
Other: 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).
Other Name: Sugar pill Behavioral: Questionnaires Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Names:
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- Symptom Reduction [ Time Frame: Baseline to 3 months (three cycles with assessments made at beginning of each) ]Minocycline tested for its ability to reduce the value of a patient's three-month (± two days) area under the curve (AUC) for five symptoms: fatigue, pain, muscle weakness, numbness, and bone aches, either in combination or individually. AUC is based on the average of five most-severe symptoms (pain, fatigue, bone aches, numbness, muscle weakness) reported by multiple myeloma (MM) patients in previous studies.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with pathologically diagnosed who have received induction chemotherapy, with or without AuSCT, and who have qualified to receive lenalidomide-based maintenance therapy for their MM.
- Patients > or = 18 years old.
- Patients able to render informed consent and to follow protocol requirements.
- Patients who speak English (due to patient-reported outcome language options, we are only accruing English-speaking patients to the protocol).
- 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].
- 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:
- Patients who are taking minocycline for other conditions, as determined by the treating physician
- Patients with hypersensitivity to tetracyclines
- Women who are pregnant or nursing; pregnancy will be confirmed by urine test
- Patients who are enrolled in other clinical trials that have symptom management as primary outcome
- Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)
- Patients taking any tetracycline in the last 15 days
- Patients on Vitamin K antagonist warfarin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793051
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Robert Orlowski, MD, PHD | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01793051 History of Changes |
| Other Study ID Numbers: |
2012-0413 P01CA124787 ( U.S. NIH Grant/Contract ) NCI-2013-00700 ( Registry Identifier: NCI CTRP ) |
| First Posted: | February 15, 2013 Key Record Dates |
| Last Update Posted: | November 24, 2017 |
| Last Verified: | November 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by M.D. Anderson Cancer Center:
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Myeloma Multiple Myeloma MM Symptom Burden Symptom reduction Maintenance therapy with lenalidomide Minocycline Dynacin Minocin |
Minocin PAC Myrac Solodyn Placebo Sugar pill MD Anderson Symptom Inventory MDASI Questionnaires Surveys |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Lenalidomide Thalidomide Minocycline Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents |