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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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. Histologically documented multiple myeloma

2. Age ≥ 18 years

3. Must have had at least ≥ 4 prior anti-myeloma therapies

4. Must have documented disease progression

5. 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 and for at
least 28 days after study treatment discontinuation.

6. 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

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Lars Sternas, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-4047-MM-009

NCT ID:

NCT01632826

Start Date:

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Relapsed
  • refractory multiple myeloma
  • pomalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Celgene Study SiteGreenbrae, California  94904
Celgene Study SiteDenver, Colorado  80218
Celgene Study SiteWest Palm Beach, Florida  33401
Celgene Study SiteMarietta, Georgia  30060
Celgene Study SitePeoria, Illinois  61615
Celgene Study SiteIndianapolis, Indiana  46202
Celgene Study SiteIowa City, Iowa  52242
Celgene Study SiteBaltimore, Maryland  21215
Celgene Study SiteHyannis, Massachusetts  02601
Celgene Study SiteSt. Louis, Missouri  63110
Celgene Study SiteOmaha, Nebraska  68198
Celgene Study SiteHackensack, New Jersey  07601
Celgene Study SiteNew York, New York  10029
Celgene Study SitePhiladelphia, Pennsylvania  19107
Celgene Study SiteGreenville, South Carolina  29615
Celgene Study SiteSioux Falls, South Dakota  57105
Celgene Study SiteDallas, Texas  75390
Celgene Study SiteSalt Lake City, Utah  84106
Celgene Study SiteMorgantown, West Virginia  26506
Celgene Study SiteMilwaukee, Wisconsin  53226