Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma



Status:Approved for marketing
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/26/2017

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A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a
likelihood of benefit from the pomalidomide treatment while the medication is not
commercially available

Several clinical studies indicate that pomalidomide has activity in relapsed and refractory
multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2
mg/day and/or 4 mg/day.

Inclusion Criteria:

1. Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma
and have measurable disease (serum or urine M-protein)

2. Age ≥ 18 years

3. Must have had at least ≥ 2 prior anti-myeloma therapies

4. Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib,
either alone or in combination

5. Must have failed treatment with the last lenalidomide-containing regimen and the last
bortezomib-containing regimen

6. Must have documented disease progression during or after the last antimyeloma regimen

7. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of
contraception simultaneously or practice complete abstinence from heterosexual
contact for at least 28 days before starting drug, while participating in the study
and for at least 28 days after study treatment discontinuation.

8. Males must agree to use a latex condom during sexual contact with FCBP while
participating in the study and for 28 days following discontinuation from study
treatment.

Exclusion Criteria:

1. Peripheral Neuropathy ≥ Grade 2

2. Non-secretory multiple myeloma

3. Previous therapy with pomalidomide

4. Use of any investigational agents within 28 days or 5 half lives (whichever is
longer) of initiating study treatment

5. Subjects with conditions requiring chronic steroid or immunosuppressive treatment.

6. Hypersensitivity to thalidomide, lenalidomide or dexamethasone

7. Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C

8. Pregnant or breastfeeding females

9. Unacceptable hematological or biochemical laboratory abnormalities
We found this trial at
26
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Marietta, Georgia 30060
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Baltimore, Maryland 21215
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Calgary, Alberta
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Dallas, Texas 75390
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Denver, Colorado 80218
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Duarte, California 91010
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Greenbrae, California 94904
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Greenville, South Carolina 29615
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Greenville, SC
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Hackensack, New Jersey 07601
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Houston, Texas 77030
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46202
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Iowa City, Iowa 52242
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Los Angeles, California 90048
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Milwaukee, Wisconsin 53226
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Morgantown, West Virginia 26506
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New York, New York 10029
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New York, New York 10029
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Omaha, Nebraska 68198
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Peoria, Illinois 61615
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Philadelphia, Pennsylvania 19107
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84106
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Sellersville, Pennsylvania 18960
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Sioux Falls, South Dakota 57105
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West Palm Beach, Florida 33401
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