Clinical trial NCT00747123: A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose to termination visit on Day 169
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
timeFrame: From first dose to termination visit on Day 169
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose up to termination visit on Day 169
measure: Change From Baseline in Hemoglobin
timeFrame: Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
measure: Number of Participants With Electrocardiogram Abnormalities
timeFrame: Pre-dose, Day 1, Day 92, and Day 169
measure: Number of Participants With Hypertension or Increased Blood Pressure
timeFrame: From baseline up to Day 92
Secondary outcomes:
measure: Number of Participants With Skeletal-related Events (SRE)
timeFrame: From first dose up to 2 weeks post first dose
measure: Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
timeFrame: From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Investigative Site
Study officials:
affiliation: Celgene Corporation
name: Abderrahmane Laadem, MD
role: STUDY_DIRECTOR
References:
citation: 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.