Waldenstrom's MacroglobulinemiaPhase 1NCT00150462
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
A Phase 1 study testing Carfilzomib and Dexamethasone in people with Waldenstrom's Macroglobulinemia and Non-Hodgkin's Lymphoma, run by Amgen at 5 sites in United States.
Trial summary
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
- What is being tested?
- Carfilzomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2005to Oct 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent in accordance with federal, local, and institutional guidelines
- Males and females ≥18 years of age
- Histologically confirmed diagnosis of one of the hematologic malignancies below:
- Multiple myeloma (MM)
- Non-Hodgkin's lymphoma (NHL)
- Waldenström's Macroglobulinemia (WM)
Show all 18Show fewer
- Hodgkin's disease (HD)
- Subjects who are refractory or relapsed following at least two prior therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate cardiovascular function without symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months
- Adequate hepatic function, with bilirubin < 2.0 times the upper limit of normal, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of < 3.0 times the upper limit of normal
- Total white blood cell (WBC) count ≥ 2,000/mm³, absolute neutrophil count (ANC) ≥ 1000/mm³, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50,000/mm³
- Screening ANC should be independent of granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for ≥ 1 week and of pegylated G-CSF for ≥ 2 weeks)
- Subjects receiving supportive care including erythropoietin, darbepoetin and/or bisphosphonates can continue to do so, but must be transfusion independent; subjects receiving erythropoietic support must remain on the same dose for the first 28 days of study participation
- An estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault
- Serum creatinine ≤ 2.0 mg/dL
- Uric acid, if elevated, must be corrected to within laboratory normal range prior to dosing
- Female subjects of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test. Male subjects must use an effective barrier method of contraception throughout the study and for three months following the last dose if sexually active with a female of child-bearing potential.
Who cannot join
- Female subjects who are pregnant or lactating
- Subjects who are transfusion dependent
- Subjects with NHL or HL who have received steroid therapy in the previous seven days
- Subjects with MM or Waldenström's Macroglobulinemia who have received steroid therapy in the previous three weeks, except for MM subjects in the Carfilzomib + DEX Expansion Cohort, where previous treatment with dexamethasone will be allowed. The dose and schedule of administration of dexamethasone will be adjusted to that used in the protocol
- Radiation, chemotherapy, or immunotherapy in the previous four weeks, or subjects who, in the judgment of the Investigator, have not recovered from the effects of previous therapy
- For the Dose Escalation period, subjects who have received prior radioimmunotherapy with anti-cluster of differentiation (CD)20 monoclonal antibodies such as Bexxar® or Zevalin®; subjects treated with these products will be allowed in the Dose Expansion period
Show all 26Show fewer
- Subjects who have received allogeneic stem cell transplant therapy
- Subjects with NHL or HL who have received autologous stem cell transplant therapy and have relapsed within 100 days of therapy
- Rituxan therapy within three months before Day 1 unless there is evidence of disease progression
- Major surgery within three weeks before Day 1
- Congestive heart failure (CHF) (New York Heart Association class III to IV)
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- Subjects who are known or suspected of having human immunodeficiency virus (HIV) infection or who are HIV seropositive
- Active hepatitis A, B, or C infection; or positive for Hepatitis C ribonucleic acid (RNA) or hepatitis B antigen
- Non-hematologic malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable prostate specific antigen (PSA) levels for three years
- Subjects with treatment-related myelodysplastic disorder
- Subjects with known brain metastasis (active central nervous system [CNS] disease only)
- Serious psychiatric or medical conditions that could interfere with treatment
- Participation in an investigational therapeutic study within one month prior to Day 1
- Significant neurotoxicity (Grade 2 or higher with pain) at the time of study initiation
- Concurrent therapy with approved or investigative anticancer therapeutics
- Subjects with previous hypersensitivity to bortezomib injection
- Subjects with contraindications to receiving allopurinol
- Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment
- Subjects with known or suspected amyloidosis
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Weil Medical College of Cornell University
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center, Columbia University
New York, New York, 10032
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
- Conditions
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Being tested
- Carfilzomib, Dexamethasone
- Keywords
- Hematological, Proteasome, Myeloma, Lymphoma
- Medical subject headings
- Waldenstrom Macroglobulinemia, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma, Neoplasms, Plasma Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
Also called PR-171, Kyprolis
Administered as an IV bolus dose
DexamethasoneDrug
Administered orally prior to carfilzomib
| Study group | Role | What they receive |
|---|---|---|
| CFZ 1.2 mg/m² | Experimental | Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 2.4 mg/m² | Experimental | Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 4.0 mg/m² | Experimental | Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 6.0 mg/m² | Experimental | Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 8.4 mg/m² | Experimental | Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 11.0 mg/m² | Experimental | Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 15.0 mg/m² | Experimental | Participants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 20.0 mg/m² | Experimental | Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 27.0 mg/m² | Experimental | Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 20/27 mg/m² | Experimental | Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Receives: Drug: Carfilzomib |
| CFZ 20/27 mg/m² + DEX | Experimental | Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly). Receives: Drug: Carfilzomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as any of the following occurring in the first 28 days of study participation:
Nonhematologic:
- > Grade 2 neuropathy with pain
- ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)
- ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy
Hematologic:
- Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support
- Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)
- Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.
Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
Measured: 28 days
Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
Measured: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)
Measured: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib
Measured: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib
Measured: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Secondary outcomes (4)
Best Clinical Response to Treatment
Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows:
- Complete response: total resolution of measurable disease parameters.
- Partial response: a ≥ 50% resolution without the appearance of new disease.
- Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.
- Progressive disease: an increase of > 25% in measurable disease parameters.
Best clinical response is the best response observed from the start of study treatment until disease progression or death.
Measured: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Duration of Response
Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.
Median duration of response was calculated using the Kaplan-Meier method.
Measured: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Time to Progression
Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.
Median time to progression was calculated using the Kaplan-Meier method.
Measured: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Progression-free Survival
Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.
Measured: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150462
- Sponsor's protocol ID
- PX-171-002
- Status last verified
- Apr 2017
- First submitted
- 6 Sep 2005
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00150462
- Acronym / sponsor ID
- PX-171-002
- Conditions
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Keywords
- Hematological, Proteasome, Myeloma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| CFZ 1.2 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 2.4 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 4.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 6.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 8.4 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 11.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 15.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 20.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 27.0 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. |
| CFZ 20/27 mg/m² | Experimental | Drug: CarfilzomibParticipants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. |
| CFZ 20/27 mg/m² + DEX | Experimental | Drug: Carfilzomib, Drug: DexamethasoneParticipants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent in accordance with federal, local, and institutional guidelines
- Males and females ≥18 years of age
- Histologically confirmed diagnosis of one of the hematologic malignancies below:
- Subjects who are refractory or relapsed following at least two prior therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Key exclusion criteria (26 listed)
- Female subjects who are pregnant or lactating
- Subjects who are transfusion dependent
- Subjects with NHL or HL who have received steroid therapy in the previous seven days
- Subjects with MM or Waldenström's Macroglobulinemia who have received steroid therapy in the previous three weeks, except for MM subjects in the Carfilzomib + DEX Expansion Cohort, where previous treatment with dexamethasone will be allowed. The dose and schedule of administration of dexamethasone will be adjusted to that used in the protocol
- Radiation, chemotherapy, or immunotherapy in the previous four weeks, or subjects who, in the judgment of the Investigator, have not recovered from the effects of previous therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarfilzomibAlso: PR-171, KyprolisAdministered as an IV bolus dose | Drug | CFZ 1.2 mg/m², CFZ 11.0 mg/m², CFZ 15.0 mg/m², CFZ 2.4 mg/m², CFZ 20.0 mg/m², CFZ 20/27 mg/m², CFZ 20/27 mg/m² + DEX, CFZ 27.0 mg/m², CFZ 4.0 mg/m², CFZ 6.0 mg/m², CFZ 8.4 mg/m² |
| DexamethasoneAdministered orally prior to carfilzomib | Drug | CFZ 20/27 mg/m² + DEX |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: 28 days
A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * > Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
Time frame: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)
Time frame: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib
Time frame: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib
Time frame: Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
4 secondary outcomes
Best Clinical Response to Treatment
Time frame: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Duration of Response
Time frame: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Time to Progression
Time frame: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Progression-free Survival
Time frame: From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Waldenstrom's Macroglobulinemia
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
Active, not recruitingPhase 2
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent
Active, not recruitingPhase 2
Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia
Waldenstrom Macroglobulinemia
Not yet recruitingPhase 2
Teclistamab In Waldenstrom's Macroglobulinemia
Waldenstrom's Macroglobulinemia
Not yet recruitingPhase 3
Evaluation of Iopofosine I 131 vs. R-CD in WM Patients
Waldenstrom Macroglobulinaemia, Waldenstrom Macroglobulinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carfilzomib and Dexamethasone in people with Waldenstrom's Macroglobulinemia and Non-Hodgkin's Lymphoma, run by Amgen at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.