Last reviewed · How we verify
LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma
Phase 1, PHASE2 trial testing Carfilzomib in Multiple Myeloma in 12 participants. Completed in 21 February 2024.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 3 January 2019 |
| Primary completion | 7 November 2022 |
| Estimated completion | 21 February 2024 |
| Sites | 2 locations across United States |
Wake Forest University Health Sciences
Adults 18 to 75, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5 mg Ruxolitinib | 0 | |
| Phase I 10 mg Ruxolitinib | 0 | |
| Phase I 15 mg Ruxolitinib | 1 |
Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of PR or better as per the IMWG criteria
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5mg Ruxolitinib | 0 | |
| Phase I 10 mg Ruxolitinib | 2 | |
| Phase I 15 mg Ruxolitibin | 1 |
Clinical benefit will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of minimal response (MR) or better as determined by the IMWG criteria
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5m Ruxolitinib | 1 | |
| Phase I 10 mg Ruxolitinib | 2 | |
| Phase I 15 mg Ruxolitinib | 1 |
Disease control will be determined for each subject as a binary variable indicating whether or not the subject achieved a disease response or stable disease for greater than or equal to 8 weeks
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5mg Ruxolitinib | 3 | |
| Phase I 10 mg Ruxolitinib | 3 | |
| Phase I 15 mg Ruxolitinib | 1 |
PFS is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death without progressive disease.
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5mg Ruxolitinib | 3.0 | 1.8 – 3.2 |
| Phase I 10mg Ruxolitinib | 6.1 | 2.6 – 8.3 |
| Phase I 15mg Ruxolitinib | 10.6 | 1.3 – 10.6 |
Time to best response will be defined as the time from initiation of ruxolitinib treatment to the time of best objective status assessment of response.
| Group | Value | 95% CI |
|---|---|---|
| Phase I 10 mg Ruxolitinib | 3.2 | 1.8 – 4.6 |
| Phase I 15 mg Ruxolitinib | 2.1 | 2.1 – 2.1 |
Overall survival is defined as the duration from initiation of ruxolitinib treatment to the date of death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5mg Ruxolitinib | 16.1 | 15.9 – 23.5 |
| Phase I 10mg Ruxolitinib | 11.2 | 5.9 – 13.1 |
| Phase I 15mg Ruxolitinib | 10.6 | 1.3 – 19.4 |
Time to progression (TTP) is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death.
| Group | Value | 95% CI |
|---|---|---|
| Phase I 5mg Ruxolitinib | 3.0 | 1.8 – 3.2 |
| Phase I 10mg Ruxolitinib | 8.3 | 4.0 – 8.3 |
| Phase I 15mg Ruxolitinib | 10.6 | 10.6 – 10.6 |
Duration of response will be defined as the time from first objective status assessment of response to the time of first documented disease progression or death.
| Group | Value | 95% CI |
|---|---|---|
| Phase I 10 mg Ruxolitinib | 4.8 | 2.2 – 7.4 |
| Phase I 15mg Ruxolitinib | 8.5 | 8.5 – 8.5 |
Time frame: Approximately 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I 5 mg Ruxolitinib | Phase I 10 mg Ruxolitinib | Phase I 15 mg Ruxolitinib |
|---|---|---|---|---|
| Sepsis | Infections and infestations | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| ALT increase | Investigations | — | — | — |
| Hepatitis viral | Infections and infestations | — | — | — |
| Lung infection | Infections and infestations | — | — | — |
| Lung infection | Infections and infestations | — | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Reaction | System | Phase I 5 mg Ruxolitinib | Phase I 10 mg Ruxolitinib | Phase I 15 mg Ruxolitinib |
|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Creatinine increased | Investigations | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Urinary frequency | Renal and urinary disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| ALT increase | Investigations | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| AST increase | Investigations | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Blurred vision | Eye disorders | — | — | — |
| Bronchial infection | Infections and infestations | — | — | — |
| Buttock pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Chest pain - cardiac | Cardiac disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Dry eye | Eye disorders | — | — | — |
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | — | — | — |
| Ear pain | Ear and labyrinth disorders | — | — | — |
| Edema limbs | General disorders | — | — | — |
| Ejection fraction decreased | Investigations | — | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Eye disorders - Other, specify | Eye disorders | — | — | — |
| Fever | Gastrointestinal disorders | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Hematuria | Renal and urinary disorders | — | — | — |
| Hypercalcemia | Metabolism and nutrition disorders | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — |
Most-reported serious reactions: Sepsis, Acute kidney injury, Anemia, ALT increase, Hepatitis viral, Lung infection, Lung infection, Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify.
Data from ClinicalTrials.gov NCT03773107 adverse events section.
The primary objective of Phase I is to establish the maximum tolerated dose (MTD) of ruxolitinib in combination with carfilzomib and dexamethasone. The primary objective of phase II is to evaluate progression-free survival (PFS) at 4 months in multiple myeloma subjects who receive the combination treatment carfilzomib, dexamethasone, and ruxolitinib.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03773107.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing