A Phase Ib multicenter dose-determination study, with an adaptive, randomized, placebo-controlled, double-blind phase II, using various repeated IV doses of BHQ880 in combination with zoledronic acid in relapsed or refractory myeloma patients with prior skeletal-related event - ND

OVARTIS FARMA0 sites267 target enrollmentMarch 31, 2009

DrugsZOMETA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: OVARTIS FARMA
Enrollment: 267
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 31, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OVARTIS FARMA

Eligibility Criteria

Inclusion Criteria

•1\.Relapsed or refractory multiple myeloma patients requiring treatment with a non\-bortezomib\-containing regimen (prior treatment with bortezomib is acceptable) 2\. The diagnosis of symptomatic multiple myeloma as defined by the following criteria (International Myeloma Working Group): M\-protein in serum or urine Clonal bone marrow plasma cells or plasmacytoma Presence of related organ or tissue impairment (ROTI) 3\. Patients with multiple myeloma who do not have measurable serum M\-protein or measurable urine M\-protein must have measurable increased concentrations of free light chains (using FreeLite?) 4\.At least one prior SRE defined as one of the following: Pathologic fracture Spinal cord compression Requirement for either radiation or surgery to bone due to: \- Pain \- Prevention of imminent fracture \- Stabilization of a fracture 5\. Stable renal function defined as two serum creatinine determinations of \< 2\.5 mg/dl or calculated (Cockroft\-Gault formula) creatinine clearance (CrCl) \< 60 mL/min. Cockcroft\-Gault formula (Cockcroft and Gault 1976\): CrCl \= \[140\-age (years)] x weight (kg) (x 0\.85 for female patients) \[72 x serum creatinine (mg/dL)] 6\. Current or planned treatment with zoledronic acid 7\. No symptoms of hyperviscosity, amyloidosis or recurrent infection 8\. Corrected serum calcium \< 12 mg/dl or ionized calcium \< 6\.5 mg/dL within 14 days prior to registration 9\. Life expectancy of at least 12 months. 10\. Ambulatory patients aged 18 years or older 11\. ECOG performance status \&\#8804; 2 12\. Absolute neutrophil count \&\#8805; 1500/mm3 13\. Platelet count \&\#8805; 75,000/mm3 14\. Hemoglobin (Hgb) \&\#8805; 9 g/dl (prior RBC transfusion, recombinant epoetin alfa, or darbepoetin alfa allowed) 15\. Electrolyte levels \&\#8805; LLN (i.e., potassium, magnesium, phosphorus) correction with supplements allowed 16\. AST and ALT \&\#8804; 2\.5 x ULN 17\. Serum bilirubin \&\#8804; 1\.5 x ULN 18\. Patients must sign the informed consent form and be willing and able to comply with the study protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism and/or Paget?s disease of bone. 2\. Current active dental problems including Ongoing infection of the teeth or jawbone (maxilla or mandibula) Current exposed bone in the mouth Dental or fixture trauma Current or previous osteonecrosis of the jaw Slow healing after dental procedures Recent (within 6 weeks) or planned dental or jaw surgery during the study (extraction, implants) 3\. Prior radiation therapy to treat diseases of the mouth 4\. Patients who are allergic to/ intolerant of bisphosphonate therapy 5\. Acute or chronic liver disease 6\. Patients with any peripheral neuropathy \&\#8805; CTCAE grade 2 7\. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled diarrhea) that could cause unacceptable safety risks or compromise compliance with the protocol 8\. Angina pectoris \&\#8804; 3 months prior to starting study drug 9\. Acute myocardial infarction \&\#8804; 6 months prior to starting study drug 10\. LVEF \< 45% 11\. Other clinically significant heart disease (e.g. symptomatic congestive heart failure, uncontrolled arrhythmia, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) 12\. A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT\-interval syndrome 13\. Patients who have not recovered from significant grade 3\-4 side effects of previous anti\-myeloma therapy 14\. Patients who have undergone major surgery \&\#8804; 2 weeks prior to starting study drug or who have not recovered from the side\-effects of surgery 15\. Patients who have received any investigational drug \&\#8804; 5 half lives prior to starting study drug or who have not recovered from side effects of such therapy. Or patients who have received previous investigational monoclonal antibody or radioimmunotherapy drug \&\#8804; 60 days prior to starting study drug or who have not recovered from side effects of such therapy 16\. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) 17\. Women of child\-bearing potential (WCBP) who are pregnant or breast feeding. WCBP, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 24 consecutive months (i.e., who have had menses any time in the preceding 24 consecutive months), must have a negative serum pregnancy test \&\#8804; 48 hours prior to starting study treatment. In addition, all sexually active WCBP and male patients must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra\-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study. 18\. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention 19\. Patients unwilling or unable to comply with the protocol