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Phase II Study to Assess the Safety, Efficacy and Tolerability of Combination Therapy With Bortezomib, Doxorubicin and Dexamethasone (PAD) as Therapy for Patients With Relapsed or Refractory Myeloma.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Phase II Study to Assess the Safety, Efficacy and Tolerability of Combination Therapy With Bortezomib, Doxorubicin and Dexamethasone (PAD) as Therapy for Patients With Relapsed or Refractory Myeloma.


Inclusion Criteria:



- Patients aged at least 18 years with MM requiring therapy for relapsed or refractory
disease.

- Previous VAD or VAD-like therapy (maximum 6 courses standard VAD). Subgroup
allocation is shown in 4.1

- Measurable serum and/or urine paraprotein, or serum free light chain

- Performance Status (PS) 0-3

- Serum bilirubin values <1.5 times the upper limit of normal

- Serum ALT/AST values <2.5 times the upper limit of normal

- Able to give informed consent

Exclusion Criteria:

- Females of child-bearing potential without a negative pregnancy test, immediately
prior to the start of PAD therapy and/or unwilling to use barrier contraceptive
precautions throughout the study or who are pregnant or breast-feeding

- Men with partners of child bearing potential unwilling to use a medically acceptable
form of contraception

- Patients with non-secretory MM and no measurable elevation of serum free light chain

- Performance status 4 (ECOG)

- Patient has a platelet count <75 x 109/L within 14 days before enrolment

- Patient has an absolute neutrophil count <1.0 x 109/L within 14 days before enrolment

- Patient has a serum creatinine > 400 mol/l at the time of enrolment

- Patient has Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI
Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) within 14 days
before enrolment

- Cardiac ejection fraction <40% by echocardiography or MUGA scan

- Known HIV seropositivity (obligatory testing is not necessary)

- Known Hepatitis B or C (obligatory testing is not necessary)

- Patients who have received more than one autologous transplant

- Use of any investigational drug within 4 weeks prior to enrolment or any patients
scheduled to receive any investigational drug during the course of the study

- Previous Bortezomib therapy

- Patients who have a medical or psychiatric condition which, in the opinion of the
investigator, contraindicates the patient's participation in this study

- Previous or concurrent malignancies at other sites, with the exception of
appropriately treated localized epithelial skin or cervical cancer. Patients with
remote histories (>5 years) of other cured tumours may be entered

- Plasma exchange within 21 days of enrolment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• To assess the response in patients with myeloma previously treated with a maximum of 6 courses of VAD (Vincristine, Doxorubicin and Dexamethasone) or VAD-like regimen and who have relapsed, or who are refractory to VAD, when treated with PAD.

Outcome Time Frame:

Patients will be followed in this study for approximately 16 months after recruitment to cover the period of PAD therapy plus one year follow up. The minimum frequency of reviews will be every two months.

Safety Issue:

No

Principal Investigator

TCM Morris

Investigator Role:

Principal Investigator

Investigator Affiliation:

Belfast City Hospital

Authority:

Ireland: Irish Medicines Board

Study ID:

ICORG 05-01 PAD

NCT ID:

NCT00567138

Start Date:

January 2006

Completion Date:

June 2008

Related Keywords:

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

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