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

Celgene30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Myeloma

Interventions

ACE-011BIOLOGICAL

ACE-011 given by the subcutaneous route of administration monthly for 4 doses.

PlaceboBIOLOGICAL

Placebo given by the subcutaneous route of administration monthly for 4 doses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Investigative Site

Moscow, Russia

Investigative Site

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A treatment emergent adverse event (TEAE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causality assessment. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported.

Time frame: From first dose to termination visit on Day 169

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug

A treatment emergent adverse event (TEAE) related to study drug was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that was determined to be related to the study drug. A TEAE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Any worsening (i.e., any clinical significant adverse change in frequency and/or intensity) of a preexisting condition, which was temporally associated with the use of the sponsor's medicinal (investigational) product, was also a TEAE. The number of participants with at least one TEAE are reported. Treatment emergent adverse events were assessed by the investigator as possibly, probably, or definitely related to the study drug.

Time frame: From first dose to termination visit on Day 169

Number of Participants With Serious Adverse Events (SAEs)

A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that at any dose (including overdose) that was fatal, was life threatening, required or prolonged inpatient hospitalization, resulted in permanent or significant disability/incapacity, or was a congenital anomaly/birth defect. The number of participants with at least one serious adverse event are reported.

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants With Skeletal-related Events (SRE)

Skeletal-related events are defined as pathologic fracture, radiation therapy to bone, surgery to bone, or spinal cord compression, within 2 weeks of study enrollment. They are determined by skeletal surveys, including x-rays of the skull, entire spine, pelvis, ribs, humeri, and femora.

Time frame: From first dose up to 2 weeks post first dose

Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)

The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation.

Time frame: From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169