Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 1 | |
| Multiple Myeloma | 15 |
Last reviewed · How we verify
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Phase 2 trial testing Carfilzomib in Multiple Myeloma in 101 participants. Completed in 17 May 2017.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 9 April 2009 |
| Primary completion | 17 May 2017 |
| Estimated completion | 17 May 2017 |
| Sites | 23 locations across Canada, United States |
Amgen — full company profile →
18 and older, any sex, with Multiple Myeloma or Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 1 | |
| Multiple Myeloma | 15 |
Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria: * Death * Life threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 7 | |
| Multiple Myeloma | 84 |
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 5 | |
| Multiple Myeloma | 66 |
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 5 | |
| Multiple Myeloma | 57 |
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 1 | |
| Multiple Myeloma | 7 |
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 5 | |
| Multiple Myeloma | 20 |
Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 1 | |
| Multiple Myeloma | 7 |
Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first. Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants. PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | 41.9 | NA – NA |
| Multiple Myeloma | 19.6 | 10.2 – 30.6 |
Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
| Group | Value | 95% CI |
|---|---|---|
| Solid Tumors | NA | NA – NA |
| Multiple Myeloma | 19.6 | 10.2 – 30.6 |
Time frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Solid Tumors | Multiple Myeloma |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Renal failure acute | Renal and urinary disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Cellulitis | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Disease progression | General disorders | — | — |
| Pain | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Pneumonia respiratory syncytial viral | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Pathological fracture | Musculoskeletal and connective tissue disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Solid Tumors | Multiple Myeloma |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Fatigue | General disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Blood creatinine increased | Investigations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Night sweats | Skin and subcutaneous tissue disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Chills | General disorders | — | — |
| Infusion site pain | General disorders | — | — |
| Sensation of pressure | General disorders | — | — |
| Seasonal allergy | Immune system disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Herpes simplex | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Dysarthria | Nervous system disorders | — | — |
| Facial palsy | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hypoaesthesia | Nervous system disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
Most-reported serious reactions: Pneumonia, Influenza, Febrile neutropenia, Renal failure acute, Dyspnoea, Cardiac failure congestive, Myocardial infarction, Diarrhoea.
Data from ClinicalTrials.gov NCT00884312 adverse events section.
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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