Multiple MyelomaPhase 1/2NCT01177683

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma

A Phase 1/2 study testing Bendamustine, Doxorubicin and Bortezomib in people with Multiple Myeloma, run by Sherif Farag, MB, BS at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination. 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, Doxorubicin and Bortezomib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 7 sitesUnited States
Study dates: Jul 2010to Dec 2017
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

A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain.
Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
Must be willing to provide correlative blood samples.

Who cannot join

Must not have received an excessive cumulative dose of anthracycline
No ≥ grade 2 peripheral neuropathy.
No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
No autologous stem cell transplant within 6 months prior to registration for protocol therapy
No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.
No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.

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No known central nervous system involvement by myeloma.
No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
No patients known to be positive for HIV, or active Hepatitis A, B, or C.
No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Community Regional Cancer Center
Indianapolis, Indiana, 46256
IU Health Arnett Cancer Center
Lafayette, Indiana, 47904
University of Rochester Medical Center
Rochester, New York, 14642
Metro Health Cancer Care
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma: Hoosier Cancer Research Network MM08-141

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

Read the detailed description

Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days

Phase II component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC >1000

1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.

ECOG Performance Status: 0-2

Hematopoietic:

Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3
Platelets ≥ 75 x K/mm3

Hepatic:

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN

Renal:

Serum creatinine < 3.0 mg/dL

Cardiovascular:

LVEF >45% corrected by MUGA scan or echocardiogram.
No unstable angina pectoris or recent myocardial infarction (within 6 months)

Conditions: Multiple Myeloma
Being tested: Bendamustine, Doxorubicin, Bortezomib, Filgrastim
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
Phase I component:
Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4
DoxorubicinDrug
Phase I and II components:
Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4
BortezomibDrug
Phase I and II components:
Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11
BendamustineDrug
Phase II component:
Bendamustine at at MTD IV over 1 hour, Days 1 and 4
FilgrastimDrug
Phase II component:
Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000

Study groups in NCT01177683
Study group	Role	What they receive
Arm 1	Experimental	Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin. Receives: Drug: Bendamustine; Drug: Doxorubicin; Drug: Bortezomib; Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin.
In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested.
Measured: From C1D1 up to a maximum of 7 months or until death
Phase II : Overall Response Rate
Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to <200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR.
Measured: From C1D1 up to a maximum of 52 months or until death

Secondary outcomes (5)

Phase I & Phase II : Toxicity of Treatment Regimen
Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined.
Measured: From C1D1 until death or up to a maximum of 54 months
Phase II : Time to Progression
The time from the start of treatment (i.e., first dose) of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin to disease progression, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date for patient without progression/death or date of death due to other diseases for patients' deaths due to other causes.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met:
Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc.
Measured: From C1D1 up to a maximum of 54 months or until death
Phase II: Progression-free Survival (PFS)
The time from the start of treatment of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. to disease progression or death (regardless of cause of death), whichever comes first. Censoring date will be the last disease evaluation date.Per modified International Myeloma Working Group criteria: Progressive disease (PD) is reported if any one of the following criteria is met:
Increase of 25% or more in serum or urine M-protein from baseline;Serum M-protein and/or the absolute increase must be ≥0.5 g/dL;Urine M-protein and/or absolute increase must be ≥200 mg/24 hours ; Development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas;Development of hyperc.
Measured: From C1D1 up to a maximum of 54 months until death
Phase II: Duration of Survival
Duration of MM patients treated with bendamustine, bortezomib and pegylated liposomal doxorubicin. from first date of at least partial response to the time of progression or death due to disease progression as events, with disease progression and death due to disease progression as events and deaths due to causes other than progression as censored. Censoring date will be the last disease evaluation date or date of death due to other causes as appropriate.
Measured: From C1D1 up to a maximum of 52 months
Phase II: Overall Survival
The time from the start of treatment to death from any cause with last date known alive as censoring date.
Measured: From C1D1 up to a maximum of 54 months or until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Dec 2017

First posted9 Aug 2010 (estimated)
Study startJul 2010
Primary completionDec 2017
Study completionDec 2017

Why it stopped: Lack of accrual

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177683
Sponsor's protocol ID: MM08-141
Status last verified: Sep 2023
First submitted: 5 Aug 2010
Last updated: 6 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma: Hoosier Cancer Research Network MM08-141
ClinicalTrials.gov ID: NCT01177683
Acronym / sponsor ID: MM08-141
Conditions: Multiple Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of accrual
Enrolment: 32 participants (actual)
Lead sponsor: Sherif Farag, MB, BSUniversity, hospital or other
Collaborators: Hoosier Cancer Research Network, Cephalon, Inc.
Study start: Jul 2010
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 6 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

Detailed description

Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days

1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.

ECOG Performance Status: 0-2

Hematopoietic:

Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3
Platelets ≥ 75 x K/mm3

Hepatic:

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN

Renal:

Serum creatinine < 3.0 mg/dL

Cardiovascular:

LVEF >45% corrected by MUGA scan or echocardiogram.
No unstable angina pectoris or recent myocardial infarction (within 6 months)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Drug: Bendamustine, Drug: Doxorubicin, Drug: Bortezomib, Drug: FilgrastimBendamustine in combination with bortezomib and pegylated liposomal doxorubicin.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain.
Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
Must be willing to provide correlative blood samples.

Key exclusion criteria (10 listed)

Must not have received an excessive cumulative dose of anthracycline
No ≥ grade 2 peripheral neuropathy.
No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
No autologous stem cell transplant within 6 months prior to registration for protocol therapy
No prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.

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
BendamustinePhase I component: Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4	Drug	Arm 1
DoxorubicinPhase I and II components: Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4	Drug	Arm 1
BortezomibPhase I and II components: Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11	Drug	Arm 1
BendamustinePhase II component: Bendamustine at at MTD IV over 1 hour, Days 1 and 4	Drug	Arm 1
FilgrastimPhase II component: Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000	Drug	Arm 1

Primary outcome

Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin.
Time frame: From C1D1 up to a maximum of 7 months or until death
In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested.
Phase II : Overall Response Rate
Time frame: From C1D1 up to a maximum of 52 months or until death
Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to <200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR.

5 secondary outcomes

Phase I & Phase II : Toxicity of Treatment Regimen
Time frame: From C1D1 until death or up to a maximum of 54 months
Phase II : Time to Progression
Time frame: From C1D1 up to a maximum of 54 months or until death
Phase II: Progression-free Survival (PFS)
Time frame: From C1D1 up to a maximum of 54 months until death
Phase II: Duration of Survival
Time frame: From C1D1 up to a maximum of 52 months
Phase II: Overall Survival
Time frame: From C1D1 up to a maximum of 54 months or until death

Results and safety

Results posted to the registry on 6 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.	3	0
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.	3	0
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.	26	2

Primary outcome: Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin.

Time frame: From C1D1 up to a maximum of 7 months or until death. Number. Unit: mg/m^2

Measure	Phase I Level 1:Bendamustine at 90 mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. n = 3	Phase I Level 2:Bendamustine at 120 mg/m^2 With Bortezomib and Pegylated Liposomal n = 3
Value	120	120

Primary outcome: Phase II : Overall Response Rate

Time frame: From C1D1 up to a maximum of 52 months or until death. Count of participants. Unit: Participants

Measure	Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. n = 24
CR+PR	14
Non-CR+PR	9
Missing	1

Population analysed: Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 54 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.	8 of 26 (30.8%)	24 of 26 (92.3%)	7 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Hoosier Oncology Group HomepageLink provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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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.

Sherif Farag, M.B., B.S. study chair

Hoosier Cancer Research Network

7 sites 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, Doxorubicin and Bortezomib in people with Multiple Myeloma, run by Sherif Farag, MB, BS at 7 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 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 6 Oct 2023). 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?

Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin. (time frame: From C1D1 up to a maximum of 7 months or until death). 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?

On the ClinicalTrials.gov record for NCT01177683.

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 6 Oct 2023.