Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 20 to 75 DUT-KWF-CKVO-8414 DUT-IKA-851

Objectives

I.  Investigate whether bisphosphonate APD influences quality of 
life/morbidity by decreasing bone resorption in patients with multiple myeloma.
II.  Determine whether bisphosphonate APD has a bone-saving effect by 
inhibiting bone resorption activity by osteoclasts (as assessed via objective 
structural changes in the skeleton).
III.  Determine whether bisphosphonate APD influences survival in patients 
with multiple myeloma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 20 to 75 years of age with 
Stage II/III multiple myeloma, diagnosed according to the criteria developed 
by Durie and Salmon, who have received no previous chemotherapy or treatment 
with APD.  A creatinine clearance greater than 30 ml/minute is required.  The 
following conditions exclude:  history of other malignant tumors except for 
curatively treated cervical carcinoma in situ and nonmelanomatous skin 
cancers; gastrointestinal ulcers or clinically manifest signs of 
malabsorption; untreatable decompensatio cordis; untreatable rhythm disorders; 
expected problematic follow-up; and other severe diseases that could be 
expected to influence survival.

Expected Enrollment

Approximately 90 patients will be entered over 3 years.

Outline

Randomized double-blind study.  The choice of the chemotherapy regimen is left 
to the participating center, but all patients treated at one center must 
receive the same regimen.
Arm I:  Bisphosphonate APD.
Arm II:  Placebo.

Trial Contact Information

Trial Lead Organizations

Onze Lieve Vrouwe Gasthuis

Klaas Roozendaal, MD, Protocol chair(Contact information may not be current)		Ph: 31-20-599-9111