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A Single-arm, Open-label, Phase 2 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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Smoldering Multiple Myeloma

Thank you

Trial Information

A Single-arm, Open-label, Phase 2 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


Inclusion Criteria:



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

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A

Outcome Time Frame:

at 6 month

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBHQ880A2204

NCT ID:

NCT01302886

Start Date:

May 2011

Completion Date:

October 2013

Related Keywords:

  • Smoldering Multiple Myeloma
  • High risk Smoldering multiple myeloma,
  • BHQ880,
  • MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)Atlanta, Georgia  30322
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
H. Lee Moffitt Cancer Center/University of South Florida SC - 3Tampa, Florida  33612
Indiana University Indiana UnivIndianapolis, Indiana  46202
Dana Farber Cancer Institute DFCI (2)Boston, Massachusetts  02115
Washington University School Of Medicine-Siteman Cancer Ctr Dept. of WUSTLSt. Louis, Missouri  63110
Hackensack University Medical Center Multiple Myeloma DivisionHackensack, New Jersey  07601
Mount Sinai School of Medicine Mt SinaiNew York, New York  10029
Duke University Medical Center Duke SCDurham, North Carolina  27710
Fred Hutchinson Cancer Research Center Fred HutchinsonSeattle, Washington  98109