Phase 2
N=30
A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00747123 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 4; 7; 7; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACE-011 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
4; 7; 7; 8 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug |
0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 1; 0; 3 | — |
| PRIMARY Change From Baseline in Hemoglobin |
0.47; 0.89; 0.83; 0.80; 0.50; -0.91 | — |
| PRIMARY Number of Participants With Electrocardiogram Abnormalities |
4; 2; 2; 2 | — |
| PRIMARY Number of Participants With Hypertension or Increased Blood Pressure |
0; 1; 0; 2 | — |
| SECONDARY Number of Participants With Skeletal-related Events (SRE) |
0; 1; 2; 2 | — |
| SECONDARY Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS) |
-6.0; -9.4; -5.8; -6.4; -7.2; -8.0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00747123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.