A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 2a, Multi-Center, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ACE-011 (hActRIIA-IgG1) in Patients With Osteolytic Lesions of Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747123
• Other study ID #: A011-04
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2008
• Est. completion date: August 1, 2009

Study information

• Verified date: October 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2009
• Est. primary completion date: August 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Patient at least 18 years of age with stage II or III multiple myeloma

• One or more lytic bone lesions

• If currently receiving bisphosphonate therapy, have been on a stable dose for = 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1

• If patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (HSCT), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since HSCT

• Has planned HSCT for the duration of the study

• Has moles or lesions that are currently undiagnosed, but are suspect for malignancy

• Has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, Paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.

Key Exclusion Criteria:

• Known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions

• History of polyneuropathy = grade 3

• Patients with plasma cell leukemia

• Planned stem cell transplant (HSCT) or radiation for the duration of the study

• Skeletal related event within 2 weeks of study enrollment

• Has received erythropoiesis-stimulating agents (ESAs) within the last 21 days or is planned to receive ESAs during the course of the study

• Has received anti-myeloma therapy within the last 21 days

• Is scheduled to receive local radiation to bone during the course of the study

• Has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment

• Woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• ACE-011
ACE-011 given by the subcutaneous route of administration monthly for 4 doses.
• Placebo
Placebo given by the subcutaneous route of administration monthly for 4 doses.

Locations

Country	Name	City	State
Russian Federation	Investigative Site	Moscow
Russian Federation	Investigative Site	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Abdulkadyrov KM, Salogub GN, Khuazheva NK, Sherman ML, Laadem A, Barger R, Knight R, Srinivasan S, Terpos E. Sotatercept in patients with osteolytic lesions of multiple myeloma. Br J Haematol. 2014 Jun;165(6):814-23. doi: 10.1111/bjh.12835. Epub 2014 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with Treatment-emergent Adverse Experiences		Up to Day 169
Primary	Change from baseline at end of treatment in Bone Specific Alkaline Phosphatase (BSAP)	BSAP is a biomarker of bone formation.	Up to Day 169
Primary	Change from baseline at end of treatment in Serum intact procollagen type I N terminal propeptide (PINP)	PINP is a biomarker of bone formation.	Up to Day 169
Primary	Change from Baseline at End of Treatment in Serum C-terminal type I collagen telopeptide (CTX)	CTX is a bone resorption biomarker.	Up to Day 169
Primary	Change from Baseline at End of Treatment in Serum tartrate-resistant acid phosphatase isoform-5b (Tracp-5b)	Tracp-5b is a bone resorption biomarker.	Up to Day 169
Secondary	Change from Baseline at End of Treatment in Hip Bone Mineral Density		Up to Day 169
Secondary	Change from Baseline at End of Treatment in Lumbar Spine Bone Mineral Density		Up to Day 169
Secondary	Summary of Investigator's Bone Lesion Assessment Based on Skeletal X-rays During Follow-up		Up to Day 169
Secondary	Change from Baseline to End of Treatment in Participant-reported Bone Pain Assessment Using a Visual Analog Scale (VAS) Score		Up to Day 169
Secondary	Participants with Skeletal-related Adverse Events		Up to Day 169
Secondary	Pharmacokinetics - AUC	Area under the plasma concentration-time curve	Up to Day 169
Secondary	Pharmacokinetics - Cmax	Maximum observed concentration	Up to 169 days
Secondary	Pharmacokinetics - Tmax	Time to maximum observed concentration	Up to 169 days
Secondary	Pharmacokinetics - t½	Elimination half-life	Up to 169 days
Secondary	Pharmacokinetics - ?z	Elimination rate constant	Up to 169 days
Secondary	Pharmacokinetics - Vz/F	Volume of distribution	Up to 169 days
Secondary	Pharmacokinetics - CL/F	Total clearance	Up to 169 days
Secondary	Pharmacokinetics - Ka	Absorption rate constant	Up to 169 days