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A Phase 1, Multicenter, Open-label, Dose-escalation Study in Japan to Determine the Tolerated Dose and to Evaluate the Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination With Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma


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

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Trial Information

A Phase 1, Multicenter, Open-label, Dose-escalation Study in Japan to Determine the Tolerated Dose and to Evaluate the Safety, Efficacy, and Pharmacokinetics of Pomalidomide Alone or in Combination With Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma


Inclusion Criteria:



- Must be ≥ 20 years of age at the time of signing the informed consent document

- The subject must understand and voluntarily sign an informed consent document prior
to any study related assessments/procedures are conducted.

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

- Subjects must have documented diagnosis of multiple myeloma and have measurable
disease

- All subjects must have had at least 2 prior lines of anti-myeloma therapy. Induction
therapy followed by stem cell transplant and consolidation/maintenance will be
considered as one line

- All subjects must have either refractory or relapsed and refractory disease defined
as documented disease progression during or within 60 days of completing their last
anti-myeloma therapy.

- Primary refractory: Subjects who have never achieved any response better than
progressive disease (PD) to any previous line of anti-myeloma therapy.

- Relapsed and refractory: Subjects who have relapsed after having achieved at
least stable disease (SD) to at least one prior regimen and then developed
progressive disease (PD) on or within 60 days of completing their last
anti-myeloma therapy.

- Subjects must have also undergone prior treatment with at least 2 cycles of
lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or
within the same regimen).

- All subjects must have received adequate prior alkylator therapy.

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

Exclusion Criteria:

- Pregnant or breastfeeding females

- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone

- ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy

- Patients unable or unwilling to undergo antithrombotic prophylactic treatment will
not be eligible to participate in this study

- Any of the following laboratory abnormalities:

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

- Platelet count < 75,000/µL for patients in whom < 50% of bone marrow nucleated
cells are plasma cells; or a platelet count < 30,000/µL for patients in whom ≥
50% of bone marrow nucleated cells are plasma cells

- Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula

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

- Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of
normal (ULN) for subjects with hereditary benign hyperbilirubinaemia

- Peripheral neuropathy ≥ Grade 2

- Patients 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

- Use of any anti-myeloma drug therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

Outcome Description:

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

Outcome Time Frame:

Up to 28 Days

Safety Issue:

Yes

Principal Investigator

Masamitsu Harata

Investigator Role:

Study Director

Investigator Affiliation:

Celgene K.K

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CC-4047-MM-004

NCT ID:

NCT01568294

Start Date:

April 2012

Completion Date:

March 2018

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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