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Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myeloma

Thank you

Trial Information

Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma


The Study Drugs:

Lenalidomide and thalidomide are drugs that alter the immune system and that may also
interfere with the development of blood vessels that help support tumor growth. This may
reduce or prevent the growth of cancer cells.

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.
Dexamethasone is often given to MM patients in combination with other chemotherapy to treat
cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you joined this study. Up to 4 groups of up to 3-6 patients
participants will be enrolled in the Phase I portion of the study, and up to 46 participants
will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of lenalidomide and thalidomide you
receive will depend on when you joined this study. The first group of participants will
receive the lowest dose level of the combination. Each new group will receive a higher dose
of the combination than the group before it, if no intolerable side effects were seen. This
will continue until the highest tolerable dose of the combination of lenalidomide and
thalidomide is found.

If you are enrolled in the Phase II portion, you will receive the combination of
lenalidomide and thalidomide at the highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of dexamethasone.

Study Drug Administration:

Each study cycle is 28 days.

On Days 1-21 of Cycles 1-8, you will take lenalidomide by mouth at the same time every day,
You should take it with a glass of water on either a full or an empty stomach. Do not
break, chew, or open the capsules.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you
miss taking your dose for the entire day, take your regular dose the next scheduled day (do
NOT take double your regular dose to make up for the missed dose).

On Days 1-28 of Cycles 1-8, you will take thalidomide by mouth. You should take thalidomide
in the evenings with a full glass (about 8 ounces) of water.

On Days 1-4, 9-12, and 17-20 of Cycles 1-2, you will take dexamethasone by mouth with meals
one time each day .

On Days 1, 8, 15, and 22 of Cycles 3-8, you will take dexamethasone by mouth one time each
day.

You will be given a diary to record when you take all of the study drugs and any problems or
illnesses you experience. You should also write down in the diary any other drugs you take
while you are on the study. You should bring this diary with you to each visit.

Maintenance Therapy Study Drug Administration:

If you are in Phase 1 or 2, after completing 8 cycles, if you have stable or responding
disease to study drugs and you have not experienced intolerable side effects, you will be
able to continue taking the study drugs on a maintenance schedule. You will stay on this
schedule for as long as you are benefitting.

- On Days 1-21 of each cycle of maintenance therapy, you will take lenalidomide by mouth.

- On Days 1-28 of each cycle of maintenance therapy, you will take thalidomide by mouth.

- If your doctor feels that it is needed, you may continue taking dexamethasone during
the maintenance period.

The dose level of lenalidomide will be the same dose you took during Cycle 8. The dose level
of thalidomide will be the lowest dose during the study (which may be a lower dose then you
were receiving during Cycles 1-8) If the doctor thinks it is needed, the doses may also be
lowered depending on how well you are tolerating the drugs.

Study Visits:

On Days 1, 8, 15, and 22 of Cycle 1, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will be asked questions about how you are feeling.

On about Day 1 of Cycles 2-8, the following tests and procedures will be performed:

- You will have a physical exam.

- You will be asked to list any drugs you have taken and about how you have felt since
your last visit.

- Your performance status will be recorded.

- Blood (about 3 tablespoons) will be drawn for routine blood tests.

- Urine will be collected to check the status of the disease. This urine will be
collected over a 24-hour period, you will be provided with a container for urine
collection.

- You will have a neurologic exam.

- You will have an ECG.

- You will have QST to check for any nerve symptoms

- You will complete the questionnaire about symptoms

- Blood (about 1 teaspoon) will be drawn to measure proteins in your blood.

- Blood (about 1 teaspoon) will be drawn to measure cytokine levels every even cycle
(Cycles 2, 4, 6 and so on).

- If the disease completely responds to the drugs, you will have a bone marrow biopsy to
confirm complete response. To collect a bone marrow biopsy, an area of the hip is
numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through
a large needle.

- If the doctor thinks it is needed, you will have x-rays of your bones to check the
status of the bone lesions.

- If the doctor thinks it is needed, you will have MRI scans of your bones to check on
the number of bone lesions.

If your doctor feels it is needed, the visits may take place more often.

You may have extra visits at any time during the study if your doctor feels it is needed for
your care.

Maintenance Therapy Study Visits:

Once a month during Maintenance Therapy, the following tests and procedures will be
performed:

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) will be drawn to measure proteins in your blood.

- Urine will be collected to check the status of the disease. This urine will be
collected over a 24-hour period, you will be provided with a container for urine
collection.

- If the disease completely responds to the drugs, you will have a bone marrow biopsy to
confirm complete response.

Length of Study:

You will receive up to 8 cycles of the study drugs. If the doctor thinks it is in your best
interest, you will continue to receive the study drugs as Maintenance Therapy for as long as
you are benefitting. You will be taken off study if the disease gets worse or you experience
intolerable side effects.

End-of-Study Visit:

If you go off study for any reason, you will have an end-of-study visit. This is usually
done about 30 days after the last dose of the study drugs. At this visit, the following
tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Blood (about 2-3 teaspoons) and urine (over 24 hours) will be collected to check the
status of the disease.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- Urine will be collected to check the status of the disease. This urine will be
collected over a 24-hour period, you will be provided with a container for urine
collection.

- If the disease completely responds to the drugs, you will have a bone marrow biopsy to
confirm complete response.

This is an investigational study. Lenalidomide is FDA approved and commercially available
for the treatment of types of myelodysplastic syndrome (MDS). Dexamethasone is FDA approved
and commercially available for use in combination with lenalidomide for the treatment of
patients with MM who have received at least 1 prior therapy. Thalidomide is FDA approved
and commercially available for the treatment of newly diagnosed myeloma. The use of this
drug combination when given to patients with relapsed or refractory MM is investigational.

Up to 64 patients will take part in this clinical research study. All will be enrolled at MD
Anderson.


Inclusion Criteria:



1. Understand and voluntarily sign an informed consent form.

2. Age >/= 18 years at the time of signing the informed consent form.

3. Relapsed/refractory MMM with measurable levels of myeloma paraprotein in serum ( >/=
0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or abnormal
free light chain (FLC) ratio.

4. Serum Creatinine
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

6. Females of childbearing potential (FCBP)* must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to
and again within 24 hours of starting lenalidomide and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional affective method AT THE
SAME TIME, at least 28 days before she starts taking lenalidomide.

7. Continuation from Inclusion # 6: FCBP must also agree to ongoing pregnancy testing.
Men must agree to use a latex condom during sexual contact with a female of
childbearing potential even if they have had a successful vasectomy. All patients
must be counseled at a minimum of every 28 days about pregnancy precautions and risks
of fetal exposure.

8. Continuation from Inclusion # 7: * A female of childbearing potential is a sexually
mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or
2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months).

9. Laboratory test results within these ranges: Absolute neutrophil count > 1000
cells/mm^3 Platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow
plasma cells and platelet count > 25,000 cells/mm^3 for patients in whom > 50% of the
bone marrow nucleated cells were plasma cells Total bilirubin (SGOT) and ALT (AGPT) < 3 x ULN

10. Able to take prophylactic anticoagulation, warfarin or equivalent agent

11. Patient is able to understand and comply with the terms and conditions of the
Lenalidomide and Thalidomide Counseling Program

12. All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®, AND the
S.T.E.P.S.® program.

Exclusion Criteria:

1. Any serious medical condition, or psychiatric illness that would prevent the subject
from signing the informed consent form

2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide).

3. Use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy
(radiation therapy allowed within 5 days of completion of radiation therapy).

4. Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.

5. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

End of Cycle 1 (28 Days)

Safety Issue:

Yes

Principal Investigator

Jatin J. Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0179

NCT ID:

NCT00966693

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Myeloma
  • Relapsed/Refractory Multiple Myeloma
  • RRMM
  • Lenalidomide
  • Revlimid
  • CC-5013
  • Thalidomide
  • Thalomid
  • Dexamethasone
  • Decadron
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030