Multiple MyelomaPhase 1/2NCT01754402
Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma
A Phase 1/2 study testing Bendamustine, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Cristina Gasparetto at 1 site in United States.
Trial summary
This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days Bendamustine: once intravenously (IV) dosing on day 1, every 28 days Dexamethasone: weekly PO or IV dosing on days 1, 8… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bendamustine, Pomalidomide 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
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2013to 1 Jan 2025
- Phase
- Phase 1/2
- 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
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study.
- Cytopathologically or histologically confirmed diagnosis of multiple myeloma
- Relapsed or refractory to most recent therapy (i.e. < 25% response, progression during therapy or within 60 days after completion).
- Refractory to prior lenalidomide therapy (i.e. history of progression on therapy using full or maximally tolerated dose of lenalidomide for >/= two cycles).
- Measurable disease:
- Serum M protein > 0.5 g/dL or
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- Urine Bence Jones protein >200 mg/24 hr or
- Elevated Free Light Chain per International Myeloma Working Group (IMWG) criteria, and abnormal ratio
- Evidence of progression/relapse
- Over 18
- Life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Total bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
- Serum creatinine <3 mg/dL
- • Absolute neutrophil count (ANC) >1.0 x 109/L or <1.0 x 109/L but > 0.75 due to >30%* marrow involvement (without granulocyte and granulocyte/macrophage colony stimulating factor (GCSF and GMCSF) for >1 week and of pegylated GCSF for >2 weeks)
- Hemoglobin >8 g/dL
- Platelet count >75.0 x 109/L or < 75.0 x 109/L but >50.0 x 109/L due to >30%* marrow involvement (without platelet transfusions for >1 week)
- Transfusions allowed if clinically indicated
- Agree to take enteric coated aspirin 81 mg daily
- Consent
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and abstain from sex or begin TWO acceptable methods of birth control >28 days before pomalidomide dose, and agree to ongoing pregnancy testing.
- Male patients must abstain from sex or use a latex condom and not donate sperm while taking pomalidomide and for 1 week after stopping drug.
- Register with POMALYST REMS™ and comply with their requirements.
Who cannot join
- Patients with known sensitivity to immunomodulatory drugs (IMiDs)
- Use of experimental drugs or therapy within 21 days of study-related drug therapy.
- Exposure to chemotherapy or steroids within 14 days of study-related drug therapy.
- Prior use of pomalidomide.
- Radiation therapy within 14 days of screening.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
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- Plasma cell leukemia.
- Waldenström's macroglobulinemia.
- Major surgery within 21 days prior to first dose.
- Pregnant or lactating females.
- Congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled or myocardial infarction in the last six months.
- Uncontrolled hypertension
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose.
- Active treatment or intervention for other malignancy or need active treatment within 8 months of starting study treatment.
- Serious psychiatric or medical conditions that interfere with treatment
- Significant neuropathy (Grade 3, Grade 4) at first dose and/or within 14 days before enrollment
- Contraindication to required concomitant drugs
- Patients with primary systemic amyloidosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I-II Study of the Combination of Bendamustine and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
This study is designed as a phase I-II, open label, dose finding study.
Study treatment will be as follows, in 28 day cycles:
- Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days
- Bendamustine: once intravenously (IV) dosing on day 1, every 28 days
- Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.
After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.
Read the detailed description
PRIMARY ENDPOINTS:
Phase I • Determination of the MTD of the combination therapy
Phase II:
- Response rate (CR+PR)
SECONDARY ENDPOINTS:
- Overall Response Rate (ORR)
- Progression Free Survival (PFS)
- Time to Progression (TTP)
- Time to next therapy
A total of 56 patients may be enrolled in this study: Dose escalation phase: Up to 24 subjects; Dose expansion phase: Up to a maximum of 38 patients treated at the maximum tolerated dose (MTD).
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. A standard 3+ 3 dose escalation schedule will be used. A minimum of 3 patients will be entered within each cohort, to be expanded to 6 patients if dose limiting toxicities (DLTs) are observed, to determine the MTD. Once the MTD is reached, any additional patients will be enrolled at the MTD level.
Dose Escalation
- Cohort -1: bendamustine 120 mg/m2; pomalidomide 2mg; dexamethasone 40mg**
- Cohort 1 (initial dose): bendamustine 120/mg/m2; pomalidomide 3 mg; dexamethasone 40 mg**
- Cohort 2: bendamustine 120 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
- Cohort 3: bendamustine 150 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
- Cohort 4: bendamustine 180 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
EVALUATION:
- For toxicity: 1 cycle (All patients will be considered evaluable for toxicity unless they cannot complete the first cycle of therapy due to withdrawal of consent or disease progression.)
- For efficacy: 2 cycles Intended treatment duration: Patients will continue on protocol as long as they are receiving clinical benefit and will be removed for disease progression (at the investigator's discretion the patient may be treated up to one cycle after progression noted to confirm progression), adverse event/unacceptable toxicity or side effect, or withdrawal of consent.
A DLT is defined as any of the following occurring during the first treatment cycle (28 days) that are judged by the investigator to be at least possibly related to the study therapy:
Hematologic:
- Febrile neutropenia (ANC <1.0x109/L) with fever of 38.5 C. Subjects who enter the study with lower counts (ANC <1.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 4 neutropenia (ANC < 0.5x109/L) for more than 7 days despite GCSF support. Subjects who enter the study with lower counts (ANC <1.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 4 thrombocytopenia (platelets count <25.0x109/L) lasting >7 days despite dose delay. Subjects who enter the study with lower counts (platelets <50.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 3-4 thrombocytopenia associated with bleeding
- Any hematologic toxicity requiring a dose reduction within Cycle 1
- Inability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days
Non-hematologic:
- Any > Grade 3 toxicity determined by the Investigator to be related to pomalidomide or bendamustine (with the exception of thrombotic events and as noted below).
- > Grade 3 nausea, vomiting, or diarrhea, despite the use of maximal antiemetic/antidiarrheal therapy
- > Grade 3 neuropathy with pain
- >Grade 3 venous thromboembolic events.
- Any Grade 4 rash related to the agents will be considered a DLT.
- A Grade 3 rash related to the agents that has not resolved to < Grade 2 within a 10 day period despite steroids therapy will be considered a DLT.
- If an event is attributed to progressive disease, it will not be counted as a DLT.
- Any non-hematologic toxicity requiring a dose reduction within Cycle 1
- Delay in ability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days
- Conditions
- Multiple Myeloma
- Being tested
- Bendamustine, Pomalidomide, Dexamethasone
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Treanda, Bendeka
Bendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles.
PomalidomideDrug
Also called CC-4047, Pomalyst
Pomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.
DexamethasoneDrug
Dexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: benda 120mg + pom 3mg | Experimental | * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
* Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
* Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days Receives: Drug: Bendamustine; Drug: Pomalidomide; Drug: Dexamethasone |
| Cohort 2: benda 120mg + pom 4mg | Experimental | * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
* Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
* Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days Receives: Drug: Bendamustine; Drug: Pomalidomide; Drug: Dexamethasone |
| Expansion | Experimental | * Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days
* Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days
* Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days Receives: Drug: Bendamustine; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Pomalidomide and Bendamustine
In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.
Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)
If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).
Measured: 2 cycles (approximately 2 months)
Initial Response Rate
The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:
CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow
PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required
VGPR - Serum and urine M-protein detectable by immunofixation but n
Measured: 2 cycles (approximately 2 months)
Secondary outcomes (4)
Overall Response Rate
The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)
sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h
SD = Not meeting criteria for CR, VGPR, PR, or progressive disease
Measured: 2 years after last dose of study drug
Time to Progression
Time to progression - defined as time elapsed in patients between achievement of response and disease progression
Measured: 2 years after last dose of study drug
Time to Next Therapy
Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy
Measured: 2 years after last dose of study drug
Progression Free Survival
The time elapsed for patients between initiation of study therapy and either disease progression or death
Measured: 2 years after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study start7 Jan 2013
- Primary completion6 Dec 2016
- Study completion1 Jan 2025 (estimated)
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 Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation with 3+3 cohort design plus Dose expansion at the Maximum tolerated dose.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina Gasparetto
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, Cristina Gasparetto, Duke University
- Investigators
- Gwynn Long, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754402
- Sponsor's protocol ID
- Pro00040206
- Other IDs
- PO-MM-PI-0045
- Status last verified
- Jan 2024
- First submitted
- 27 Nov 2012
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of the Combination of Bendamustine and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01754402
- Acronym / sponsor ID
- Pro00040206
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cristina GasparettoUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a phase I-II, open label, dose finding study.
Study treatment will be as follows, in 28 day cycles:
- Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days
- Bendamustine: once intravenously (IV) dosing on day 1, every 28 days
- Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22.
After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.
Detailed description
PRIMARY ENDPOINTS:
Phase I • Determination of the MTD of the combination therapy
Phase II:
- Response rate (CR+PR)
SECONDARY ENDPOINTS:
- Overall Response Rate (ORR)
- Progression Free Survival (PFS)
- Time to Progression (TTP)
- Time to next therapy
A total of 56 patients may be enrolled in this study: Dose escalation phase: Up to 24 subjects; Dose expansion phase: Up to a maximum of 38 patients treated at the maximum tolerated dose (MTD).
Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. A standard 3+ 3 dose escalation schedule will be used. A minimum of 3 patients will be entered within each cohort, to be expanded to 6 patients if dose limiting toxicities (DLTs) are observed, to determine the MTD. Once the MTD is reached, any additional patients will be enrolled at the MTD level.
Dose Escalation
- Cohort -1: bendamustine 120 mg/m2; pomalidomide 2mg; dexamethasone 40mg**
- Cohort 1 (initial dose): bendamustine 120/mg/m2; pomalidomide 3 mg; dexamethasone 40 mg**
- Cohort 2: bendamustine 120 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
- Cohort 3: bendamustine 150 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
- Cohort 4: bendamustine 180 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg**
EVALUATION:
- For toxicity: 1 cycle (All patients will be considered evaluable for toxicity unless they cannot complete the first cycle of therapy due to withdrawal of consent or disease progression.)
- For efficacy: 2 cycles Intended treatment duration: Patients will continue on protocol as long as they are receiving clinical benefit and will be removed for disease progression (at the investigator's discretion the patient may be treated up to one cycle after progression noted to confirm progression), adverse event/unacceptable toxicity or side effect, or withdrawal of consent.
A DLT is defined as any of the following occurring during the first treatment cycle (28 days) that are judged by the investigator to be at least possibly related to the study therapy:
Hematologic:
- Febrile neutropenia (ANC <1.0x109/L) with fever of 38.5 C. Subjects who enter the study with lower counts (ANC <1.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 4 neutropenia (ANC < 0.5x109/L) for more than 7 days despite GCSF support. Subjects who enter the study with lower counts (ANC <1.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 4 thrombocytopenia (platelets count <25.0x109/L) lasting >7 days despite dose delay. Subjects who enter the study with lower counts (platelets <50.0x109/L) due to >5030%* marrow involvement will not be evaluated for this portion of the DLT definition.
- Grade 3-4 thrombocytopenia associated with bleeding
- Any hematologic toxicity requiring a dose reduction within Cycle 1
- Inability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days
Non-hematologic:
- Any > Grade 3 toxicity determined by the Investigator to be related to pomalidomide or bendamustine (with the exception of thrombotic events and as noted below).
- > Grade 3 nausea, vomiting, or diarrhea, despite the use of maximal antiemetic/antidiarrheal therapy
- > Grade 3 neuropathy with pain
- >Grade 3 venous thromboembolic events.
- Any Grade 4 rash related to the agents will be considered a DLT.
- A Grade 3 rash related to the agents that has not resolved to < Grade 2 within a 10 day period despite steroids therapy will be considered a DLT.
- If an event is attributed to progressive disease, it will not be counted as a DLT.
- Any non-hematologic toxicity requiring a dose reduction within Cycle 1
- Delay in ability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation with 3+3 cohort design plus Dose expansion at the Maximum tolerated dose.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: benda 120mg + pom 3mg | Experimental | Drug: Bendamustine, Drug: Pomalidomide, Drug: Dexamethasone* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days |
| Cohort 2: benda 120mg + pom 4mg | Experimental | Drug: Bendamustine, Drug: Pomalidomide, Drug: Dexamethasone* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days |
| Expansion | Experimental | Drug: Bendamustine, Drug: Pomalidomide, Drug: Dexamethasone* Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study.
- Cytopathologically or histologically confirmed diagnosis of multiple myeloma
- Relapsed or refractory to most recent therapy (i.e. < 25% response, progression during therapy or within 60 days after completion).
- Refractory to prior lenalidomide therapy (i.e. history of progression on therapy using full or maximally tolerated dose of lenalidomide for >/= two cycles).
- Measurable disease:
Key exclusion criteria (18 listed)
- Patients with known sensitivity to immunomodulatory drugs (IMiDs)
- Use of experimental drugs or therapy within 21 days of study-related drug therapy.
- Exposure to chemotherapy or steroids within 14 days of study-related drug therapy.
- Prior use of pomalidomide.
- Radiation therapy within 14 days of screening.
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 |
|---|---|---|
| BendamustineAlso: Treanda, BendekaBendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles. | Drug | Cohort 1: benda 120mg + pom 3mg, Cohort 2: benda 120mg + pom 4mg, Expansion |
| PomalidomideAlso: CC-4047, PomalystPomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death. | Drug | Cohort 1: benda 120mg + pom 3mg, Cohort 2: benda 120mg + pom 4mg, Expansion |
| DexamethasoneDexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle. | Drug | Cohort 1: benda 120mg + pom 3mg, Cohort 2: benda 120mg + pom 4mg, Expansion |
Primary outcome
Maximum Tolerated Dose of Pomalidomide and Bendamustine
Time frame: 2 cycles (approximately 2 months)
In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg) If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).
Initial Response Rate
Time frame: 2 cycles (approximately 2 months)
The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as: CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required VGPR - Serum and urine M-protein detectable by immunofixation but n
4 secondary outcomes
Overall Response Rate
Time frame: 2 years after last dose of study drug
Time to Progression
Time frame: 2 years after last dose of study drug
Time to Next Therapy
Time frame: 2 years after last dose of study drug
Progression Free Survival
Time frame: 2 years after last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gwynn Long, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bendamustine, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Cristina Gasparetto at 1 site 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 23 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Feb 2017). 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?
Maximum Tolerated Dose of Pomalidomide and Bendamustine (time frame: 2 cycles (approximately 2 months)). The study lists 2 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 20 Feb 2024.