Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response.

Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved).

The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.

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

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• 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:

• Histologic confirmation of multiple myeloma

• Patients must have active multiple myeloma requiring first line treatment

• At least 18 years of age

• Female patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 3 months after completing treatment.

• Male patient agrees to use an acceptable method of contraception for the duration of the study and for 3 months after completing treatment.

• Expected survival of at least 6 months

• Patients with abnormal kidney function, including patients on dialysis, are eligible if kidney insufficiency is secondary to multiple myeloma.

• Patients must have adequate liver functions

• Patients may have received up to 2 weeks of high dose steroids. Prior steroid treatment for more than 2 weeks is allowed provided the treatment was given for neurological compromise.

• Prior radiation therapy will be allowed but radiation therapy must be completed prior to registration.

Exclusion Criteria:

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

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Patient had a myocardial infarction within 6 months of enrollment, history of cardiac disease, or clinical evidence of congestive heart failure.

• Patient previously received 250 mg/m2 or more of doxorubicin (or equivalent for other anthracyclines).

• Patient is known to be human immunodeficiency virus (HIV)-positive (patients assessed to be at risk should be tested).

• Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection (patients assessed by the investigator to be at risk should be tested)

• Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.

• Patient has hypersensitivity to bortezomib, boron or mannitol, conventional doxorubicin HCL or the components of Doxil, or other study drugs.

• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

• Patient is currently receiving other investigational drug(s).