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A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency


Phase 2
55 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Renal Insufficiency

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Trial Information

A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency


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/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Time to first SRE from randomization

Outcome Time Frame:

18-month median time to first SRE assumed for the placebo arm

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBHQ880A2203

NCT ID:

NCT01337752

Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Multiple Myeloma
  • Renal Insufficiency
  • multiple myeloma
  • renal insufficiency
  • untreated multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Renal Insufficiency

Name

Location

Medical Oncology Associates, PSSpokane, Washington  99208
University Chicago Hospital Dept. of Univ of Chicago (2)Chicago, Illinois  60637