Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

Study Groups:

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.

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