Multiple Myeloma, Renal Insufficiency
Conditions
Keywords
multiple myeloma, renal insufficiency, untreated multiple myeloma
Brief summary
The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
Interventions
DRUGBHQ880
DRUGBHQ880 Placebo
Intravenous infusion
DRUGbortezomib
intravenous injection
DRUGdexamethasone
Oral
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of multiple myeloma 2. Life expectancy of more than 6 months in the absence of intervention 3. Must not have received previous or be receiving current antimyeloma therapies 4. Renal insufficiency 5. Recovered from the effects of any prior surgery or radiotherapy
Exclusion criteria
1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry 2. Paget's disease of bone or uncorrected hyperparathyroidism 3. Impaired cardiac function 4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection 5. Pregnant or nursing (lactating) women, 6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone | 18-month median time to first SRE assumed for the placebo arm | Time to first SRE from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone | From screening through month 17 | Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity |
| Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib | At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34 | Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880). |
| Evaluate the effect of BHQ880 on bone metabolism | At screening and at months 3, 6, 12, and 18 | 1\) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), from randomization to 12 and 18 months; 2) Change in bone strength, measured by quantitative computed tomography (qCT), from randomization to 3 and 6 months |
| Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone. | From the first dose of study medication through month 17 | 1\) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880 |
Countries
Spain, United Kingdom, United States
Outcome results
None listed