PAD. ICORG 05-01, V11

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin and dexamethasone works in treating patients with multiple myeloma that has relapsed or not responded to treatment.

PATIENT POPULATION: Patients with relapsed or refractory multiple myeloma requiring therapy will be invited to participate in this study. Eligible patients will be >18 years old and able to give fully informed consent. Patients must have a Performance Score (PS) of 0-3 (ECOG), measurable serum and/or urine paraprotein, or serum free light chain, bilirubin value of less than one and a half times the upper limit of normal with ALT/AST values less than two and a half times the upper limit of normal. Patients with non-secretory multiple myeloma are excluded from this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Trials Ireland
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

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

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

3. Measurable serum and/or urine paraprotein, or serum free light chain

4. Performance Status (PS) 0-3 (ECOG - see Appendix B)

5. Serum bilirubin values <1.5 times the upper limit of normal

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

7. Able to give informed consent

Exclusion criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

1. 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

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

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

4. Performance status 4 (ECOG)

5. Patient has a platelet count <75 x 10^9/L within 14 days before enrolment

6. Patient has an absolute neutrophil count <1.0 x 10^9/L within 14 days before enrolment

7. Patient has a serum creatinine > 400 micromol/l at the time of enrolment

8. Patient has Grade 2 or greater than 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

9. Cardiac ejection fraction <40% by echocardiography or MUGA scan

10. Known HIV seropositivity (obligatory testing is not necessary)

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

12. Patients who have received more than one autologous transplant

13. 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

14. Previous Bortezomib therapy

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

16. 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

17. Plasma exchange within 21 days of enrolment