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A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics (PK) and Safety of Pomalidomide (POM) When Given in Combination With Low Dose Dexamethasone (LD-DEX) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Impaired Renal Function


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

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Trial Information

A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics (PK) and Safety of Pomalidomide (POM) When Given in Combination With Low Dose Dexamethasone (LD-DEX) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Impaired Renal Function


The primary objective of the study is to determine the PK and safety for the combination of
POM + (LD-DEX) in subjects with RRMM and impaired renal function.

The secondary objective of the study is to evaluate the efficacy of POM + (LD-DEX) in
subjects with RRMM and impaired renal function

Three Cohorts may be enrolled: A, B and C. Prior to initiation of Cohort C, the safety and
PK data from the first 28-day treatment cycle of subjects in Stage 1 will be evaluated. The
starting dose (dose level 1) as well as dose escalation steps for Cohort C will be based on
this evaluation of Stage 1 data. The protocol will be amended to include the rationale for
the selection of dose level(s) and to detail the escalation rules for Cohort C.


Inclusion Criteria:



Subjects must satisfy the following criteria to be enrolled in the study:

1. Must be ≥ 18 years at the time of signing the informed consent form

2. Must understand and voluntarily sign an informed consent document prior to any
study-related assessments/procedures

3. Must be able to adhere to the study visit schedule and other protocol requirements

4. Must have documented diagnosis of relapsed or refractory multiple myeloma and have
measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours)

5. Must have had at least 1 prior anti-myeloma regimen

6. Must have documented progression as per the International Myeloma Working Group
uniform response criteria (Durie, 2006) during or after the last anti-myeloma regimen

7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

8. 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 study drug, while participating in the
study (including dose interruptions), and for at least 28 days after study treatment
discontinuation, and must agree to regular pregnancy testing during this timeframe

9. Females must agree to abstain from breastfeeding during study participation and for
28 following discontinuation from study treatment

10. Males must agree to use a latex condom during any sexual contact with FCBP while
participating in the study and for 28 days following discontinuation from study
treatment, even if he has undergone a successful vasectomy

11. Males must also agree to refrain from donating semen or sperm while on pomalidomide
and for 28 days after discontinuation from study treatment

12. All subjects must agree to refrain from donating blood while on study drug and for 28
days after discontinuation from study treatment

13. All subjects must agree not to share medication

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Peripheral neuropathy ≥ Grade 2

2. Non-secretory multiple myeloma

3. Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) < 1,000/µL

- Platelet count < 75,000/µL

- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)

- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human
erythropoietin use is permitted)

- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or
serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) > 3.0 x
upper limit of normal (ULN)

- Serum total bilirubin > 2.0 mg/dL

4. Prior history of malignancies, other than the disease being studied, unless the
subject has been free of the malignancy for ≥ 5 years from initiating study
treatment, with the following exceptions:

- Basal cell carcinoma of the skin

- Squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix

- Carcinoma in situ of the breast

- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM
[tumor, nodes, metastasis] clinical staging system).

5. Previous therapy with Pomalidomide

6. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone

7. Rash ≥ Grade 3 during prior thalidomide or lenalidomide therapy

8. Incidence of gastrointestinal disease that may significantly alter the absorption of
pomalidomide

9. Subjects with any one of the following:

- Congestive heart failure (New York Heart Association Class III or IV)

- Myocardial infarction within 12 months prior to starting study treatment

- Unstable or poorly controlled angina pectoris, including Prinzmetal variant
angina pectoris

10. Subjects who received any of the following within the last 14 days of initiation of
study treatment:

- Plasmapheresis

- Major surgery (kyphoplasty is not considered major surgery)

- Radiation therapy (with the exception of radiation therapy to a pathological
fracture site to enhance bone healing or to treat post-fracture pain that is
refractory to narcotic analgesics)

- Any anti-myeloma drug therapy

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

12. Subjects with conditions requiring chronic steroid or immunosuppressive treatment,
such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need
additional steroid or immunosuppressive treatments in addition to the study
treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or
equivalent) within 3 weeks prior to initiating study treatment

13. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will
not be eligible to participate in this study

14. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study

15. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subjects from signing the informed consent form

16. Pregnant or breastfeeding females

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PK-Area under the plasma concentration time curve (AUC)

Outcome Description:

PK-Area under the plasma concentration time curve (AUC)

Outcome Time Frame:

Up to 24 times over 7 months

Safety Issue:

No

Principal Investigator

Lars Sternas, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-4047-MM-008

NCT ID:

NCT01575925

Start Date:

April 2012

Completion Date:

August 2016

Related Keywords:

  • Multiple Myeloma
  • Pomalidomide for Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Renal Insufficiency

Name

Location

MD AndersonHouston, Texas  77230
Colorado Blood Cancer InstituteDenver, Colorado  80218
John Theurer Cancer Center-Hackensack University Medical CenterHackensack, New Jersey  07601
Cleveland Clinic-Taussig Cancer CenterCleveland, Ohio  44195