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
Verified date | October 2019 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multi-center, randomized, multiple-dose study to evaluate the safety, tolerability and efficacy of ACE-011 in patients with osteolytic lesions of multiple myeloma.
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) |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Investigative Site | Moscow | |
Russian Federation | Investigative Site | Saint-Petersburg |
Lead Sponsor | Collaborator |
---|---|
Celgene |
Russian Federation,
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
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 |
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