A Phase 1/2 interventional study of Bendamustine and Carfilzomib in Multiple Myeloma, sponsored by Suzanne Lentzsch, MD. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Suzanne Lentzsch, MD · Phase 1/2, Interventional, and Treatment
This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma (MM).
Multiple myeloma (MM) is a malignant plasma cell disorder resulting in approximately 11,000 deaths in the United States each year. It is estimated that between 60,000-80,000 people are currently under treatment for refractory or relapsed MM. Prognosis and survival have improved over the last 20 years, but the disease is still universally fatal despite efforts to develop new and more effective chemotherapeutic regimens. Therefore, new regimens need to be developed for patients prior to peripheral blood stem cell transplant and for those unable to tolerate the toxicity of transplant.
An IRB-approved long-term retrospective chart review study (IRB-AAAU4389) was conducted to collect data for Outcome Measures relating to long-term analysis (up to 6.5 years).
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 23 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →This is the only study on the registry with Suzanne Lentzsch, MD as lead sponsor.
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Exclusion Criteria:
Subjects will receive Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days with dose escalation from 27, 36, 45 to 56 mg/ m2 . No matter what target dose the subject will receive, days 1 and 2 doses in the first cycle will always be 20 mg/m2, followed by target dose for all subsequent dates and cycles. Bendamustine will be given IV on days 1 and 2 with dose escalation up to 90 mg/m2 and dexamethasone 20 mg orally or intravenously on 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first.
Drug: Bendamustine · Drug: Carfilzomib · Drug: Dexamethasone
Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle. Dose escalation is as follows: -1 \| 60 mg/m2 1. \| 70 mg/m2 2. \| 70 mg/m2 3. \| 90 mg/m2 4. \| 90mg/m2 5. \| 90 mg/m2
Also known as: Treanda
Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days. Dose Escalation is as follows: -1 \| 27 mg/m2 1. \| 27 mg/m2 2. \| 36 mg/m2 3. \| 36 mg/m2 4. \| 45 mg/m2 5. \| 56 mg/m2
Also known as: Kyprolis, CFZ
Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.
Also known as: Decadron, Dexamethasone Intensol, Dexpak Taperpak
Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
Time frame: 6 months
Overall Response Rate (ORR)
ORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.
Time frame: 2 years
Time to Next Treatment (TTNT)
The TTNT is measured from the date of initiation of treatment to the start date of the next treatment regimen.
Time frame: Up to 6.5 years
Progression Free Survival (PFS)
PFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.
Time frame: Up to 6.5 Years
Time to Best Response
Time to the best response recorded.
Time frame: 2 years
Overall Survival (OS) Rate
The percentage of people who are still alive.
Time frame: Up to 6.5 Years
Number of Adverse Events (AEs)
Total number of AEs observed.
Time frame: 30 Days Post Last Dose, Up to approximately 9 months
| Milestone | Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg |
|---|---|---|---|---|---|
| Started | 2 | 0 | 0 | 0 | 0 |
| Completed | 1 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 |
| Milestone | Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg |
|---|---|---|---|---|---|
| Started | 0 | 1 | 0 | 0 | 0 |
| Completed | 0 | 1 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg |
|---|---|---|---|---|---|
| Started | 0 | 0 | 1 | 0 | 0 |
| Completed | 0 | 0 | 1 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 1 | 0 |
| Completed | 0 | 0 | 0 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg | Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg | Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 15 |
| Completed | 0 | 0 | 0 | 0 | 15 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
| mg/m^2 | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone | 56 |
ORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.
| participants | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Overall Response Rate (ORR) | 19 |
The TTNT is measured from the date of initiation of treatment to the start date of the next treatment regimen.
| months | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Time to Next Treatment (TTNT) | 77.0 (36.1 to NA) |
PFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.
| Months | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Progression Free Survival (PFS) | 77 (34.5 to NA) |
Time to the best response recorded.
| Months | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Time to Best Response | 10.23 (4.87 to 12.96) |
The percentage of people who are still alive.
| Participants | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Overall Survival (OS) Rate | 17 |
Total number of AEs observed.
| Adverse Events | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Number of Adverse Events (AEs) | 106 |
Collected over Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CFZ With Bendamustine and Dexamethasone | 2/20 (10%) | 7/20 (35%) | 20/20 (100%) |
| Event | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Lung infectionInfections and infestations | 3/20 |
| General disorders and administration site conditionsGeneral disorders | 2/20 |
| Infections and infestationsInfections and infestations | 2/20 |
| Abdominal infectionInfections and infestations | 1/20 |
| Abdominal painGastrointestinal disorders | 1/20 |
| Acute kidney injuryRenal and urinary disorders | 1/20 |
| Back painMusculoskeletal and connective tissue disorders | 1/20 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/20 |
| Gastrointestinal disordersGastrointestinal disorders | 1/20 |
| HyperglycemiaMetabolism and nutrition disorders | 1/20 |
| Event | CFZ With Bendamustine and Dexamethasone |
|---|---|
| AnemiaBlood and lymphatic system disorders | 13/20 |
| Platelet count decreasedInvestigations | 13/20 |
| Edema limbsGeneral disorders | 10/20 |
| Immune system disorderImmune system disorders | 9/20 |
| NauseaGastrointestinal disorders | 9/20 |
| DiarrheaGastrointestinal disorders | 8/20 |
| Neutrophil count decreasedInvestigations | 8/20 |
| Creatinine increasedInvestigations | 7/20 |
| HeadacheNervous system disorders | 7/20 |
| Lymphocyte count decreasedInvestigations | 7/20 |
Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
| Age, Continuous(years) | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Median | 65 (48 to 74) |
| Sex: Female, Male(Participants) | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Female | 6 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | CFZ With Bendamustine and Dexamethasone |
|---|---|
| Hispanic | 7 |
| Non-Hispanic | 13 |
| Region of Enrollment(Participants) | CFZ With Bendamustine and Dexamethasone |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
The record gives a start of Nov 2013, a primary completion of Mar 2019 and a completion of Jul 2023. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2024, 5 years 6 months after primary completion.
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bendamustine · Carfilzomib · Dexamethasone