Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01337752
• Collaborator: (none)
• Enrollment: 9
• Locations: 8
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Renal Insufficiency	Drug: BHQ880; Drug: BHQ880 Placebo; Drug: bortezomib; Drug: dexamethasone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BHQ880 + bortezomib and dexamethasone	Drug: BHQ880; Drug: bortezomib; intravenous injection; Drug: dexamethasone; Oral
Placebo Comparator: BHQ880 Placebo + bortezomib and dexamethasone	Drug: BHQ880 Placebo; Intravenous infusion; Drug: bortezomib; intravenous injection; Drug: dexamethasone; Oral

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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).

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Chicago Hospital Dept. of Univ of Chicago (2)	Chicago	Illinois	United States	60637
2	Medical Oncology Associates, PS	Spokane	Washington	United States	99208
3	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46026
4	Novartis Investigative Site	Madrid		Spain	28006
5	Novartis Investigative Site	Bournemouth		United Kingdom	BH7 7DW
6	Novartis Investigative Site	Manchester		United Kingdom	M13 9WL
7	Novartis Investigative Site	Oxford		United Kingdom	OX3 7LJ
8	Novartis Investigative Site	Southampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CBHQ880A2203 from the Novartis Clinical Trials website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01337752
• Other Study ID Numbers: CBHQ880A2203; 2009-010875-26
• First Posted: Apr 19, 2011
• Last Update Posted: Dec 17, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Novartis Pharmaceuticals: multiple myeloma; renal insufficiency; untreated multiple myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Renal Insufficiency; Dexamethasone; Bortezomib; Antibodies, Monoclonal

Study Results

No Results Posted as of Dec 17, 2020