Multiple MyelomaPhase 1NCT02315157
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
A Phase 1 study testing Bendamustine in people with Multiple Myeloma and Plasma Cell Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy
- Age up to 80 years
- ECOG Performance Status of 0 or 1
- Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
- FEV1, FVC and DLCO =/> 40%. No symptomatic pulmonary disease.
- Serum bilirubin <2 x upper limit of normal, alkaline phosphatase <3 x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites > 1 L prior to drainage.
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- HIV negative
- Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
- Patients or guardian able to sign informed consent
- Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg)
- Calculated GFR > 50 ml/minute
Who cannot join
- Patients with uncontrolled hypertension (systolic > 140, diastolic > 90 despite antihypertensive therapy
- Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
- New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Relapsed/refractory myeloma
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma.
SECONDARY OBJECTIVES:
- To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma.
II. To describe the response after bendamustine
OUTLINE: This is a dose-escalation study.
Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Being tested
- Bendamustine
- Keywords
- Partial Response
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Treakisym, Ribomustin, Levact, Treanda
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine 200 mg/m2 | Experimental | Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2). Receives: Drug: Bendamustine |
| Bendamustine 250 mg/m2 | Experimental | Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2). Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of bendamustine
Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 2 days
Secondary outcomes (1)
Incidence of toxicity (NCI CTCAE version 4.0)
Graded according to NCI CTCAE version 4.0
Measured: Up to 92 days following the last administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJun 2014 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Withdrawn by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Sharma, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315157
- Sponsor's protocol ID
- 14D.244
- Other IDs
- 2014-009, JT 5775
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2014
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02315157
- Acronym / sponsor ID
- 14D.244
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Keywords
- Partial Response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jun 2014 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description
PRIMARY OBJECTIVES:
- To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma.
SECONDARY OBJECTIVES:
- To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma.
II. To describe the response after bendamustine
OUTLINE: This is a dose-escalation study.
Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bendamustine 200 mg/m2 | Experimental | Drug: BendamustinePatients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2). |
| Bendamustine 250 mg/m2 | Experimental | Drug: BendamustinePatients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy
- Age up to 80 years
- ECOG Performance Status of 0 or 1
- Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
- FEV1, FVC and DLCO =/> 40%. No symptomatic pulmonary disease.
Key exclusion criteria (4 listed)
- Patients with uncontrolled hypertension (systolic > 140, diastolic > 90 despite antihypertensive therapy
- Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
- New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Relapsed/refractory myeloma
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: Treakisym, Ribomustin, Levact, TreandaGiven IV | Drug | Bendamustine 200 mg/m2, Bendamustine 250 mg/m2 |
Primary outcome
Maximum tolerated dose of bendamustine
Time frame: 2 days
Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
1 secondary outcome
Incidence of toxicity (NCI CTCAE version 4.0)
Time frame: Up to 92 days following the last administration of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Jefferson University HospitalsLink provided by the sponsor.
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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.
Manish Sharma, MD principal investigator
Thomas Jefferson 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 study testing Bendamustine in people with Multiple Myeloma and Plasma Cell Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 11 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Oct 2025. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 bendamustine (time frame: 2 days). 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 15 Oct 2025.