Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Multiple Myeloma

BHQ880 for High Risk Smoldering Multiple Myeloma (2482)
A Single-Arm, Open-Label, Phase II Clinical Trial Evaluating Disease Response following Treatment with Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients with High-risk, Smoldering Multiple Myeloma
Status Conditions Phase Study ID
Closed Multiple Myeloma (MM) Phase II 2482
NCT01302886
Summary

Purpose:   This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD, and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.


Investigator
Bill Bensinger, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
    1. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR
    2. BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0
  2. No previous or current anti-myeloma therapies
  3. Patients ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1 
Exclusions (conditions that would prevent participation in this study)
  1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid
  2. Another primary malignant disease that requires systemic treatment
  3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease
  4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
  5. Treatment with an investigational product within 28 days before the first dose of study treatment
  6. Pregnant or nursing (lactating) women
  7. Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

Other protocol-defined inclusion/exclusion criteria may apply

 

Last Updated
December 21, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.