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
sites
Milwaukee, Wisconsin 53226
1729
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Milwaukee, WI
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Baltimore, Maryland 21215
2297
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Baltimore, MD
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Calgary, Alberta
1189
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Calgary,
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Dallas, Texas 75390
1221
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Dallas, TX
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Denver, Colorado 80218
817
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Denver, CO
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Duarte, California 91010
5
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Duarte, CA
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Greenbrae, California 94904
367
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Greenbrae, CA
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Greenville, South Carolina 29615
2018
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Greenville, SC
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Hackensack, New Jersey 07601
2430
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Hackensack, NJ
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Houston, Texas 77030
1474
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Houston, TX
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Hyannis, Massachusetts 02601
2621
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Hyannis, MA
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Indianapolis, Indiana 46202
1793
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Indianapolis, IN
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Iowa City, Iowa 52242
1529
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Iowa City, IA
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Los Angeles, California 90048
20
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Los Angeles, CA
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Marietta, Georgia 30060
1907
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Marietta, GA
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Morgantown, West Virginia 26506
2122
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Morgantown, WV
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New York, New York 10029
213
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New York, NY
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New York, New York 10029
213
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New York, NY
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Omaha, Nebraska 68198
1298
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Omaha, NE
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Peoria, Illinois 61615
1618
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Peoria, IL
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Philadelphia, Pennsylvania 19107
2375
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Philadelphia, PA
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Saint Louis, Missouri 63110
1573
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Saint Louis, MO
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Salt Lake City, Utah 84106
569
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Salt Lake City, UT
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Sellersville, Pennsylvania 18960
2365
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Sellersville, PA
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Sioux Falls, South Dakota 57105
1313
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Sioux Falls, SD
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West Palm Beach, Florida 33401
2304
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West Palm Beach, FL
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