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A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myeloma

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Trial Information

A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma


Study Groups:

If you agree to take part in this study, you 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 you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.

Study Drug Administration:

You 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 you begin your lenalidomide therapy.

You should take the study drug/placebo with a full glass (8 ounces) of water. You may take
it with or without food, but if the study drug/placebo causes an upset stomach, you should
take it with food.

You check with the study doctor about continuing any drugs you are currently taking. The
study drug may not mix well with other drugs. You should not take bismuth (Pepto-Bismol),
calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine,
didanosine, and/or antacids within 2 hours of taking the study drug. You should also avoid
alcohol (including wine, beer, and liquor), driving, and doing other tasks or activities
until you learn how the study drug affects you.

Study Visits:

You must bring the study drug/placebo container, along with any remaining drug, with you to
your 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 you start lenalidomide therapy:

- You 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 also be asked questions about your demographic information,
such as your marital status, job status, education, and race will also be collected.

During lenalidomide therapy:

-You will complete a symptom questionnaire in the clinic or by telephone 1 time each week
about any symptoms you may be having and how they may be affecting your daily activities.
The symptom questionnaire should take about 3-5 minutes to complete each time.

During your clinic visit at each new cycle of lenalidomide therapy, you will fill out 3
questionnaires about your 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.

End-of-Treatment Visit:

You will have an end-of-treatment visit at the end of month 3. At this visit, you will
complete 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes
to complete all of the questionnaires.

Length of Study:

You may continue taking the study drug/placebo for up to 3 months. You will no longer be
able to take the study drug if the disease gets worse, if intolerable side effects occur, if
you are unable to follow study directions, or the study doctor thinks it is in your 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 patients will take part in this study. All will be enrolled at MD Anderson Cancer
Center.


Inclusion Criteria:



1. 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.

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:

1. Patients who are taking minocycline for other conditions, as determined by the
treating physician

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Symptom Reduction

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Robert Orlowski, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0413

NCT ID:

NCT01793051

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Myeloma
  • 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
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030