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Cancer drug dose study canceled before it began

NCT ID NCT02315157

Knowledge-focused Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to find the safest and most effective dose of the chemotherapy drug bendamustine for people with multiple myeloma that had not been cured by earlier treatments. It was a Phase 1 trial, meaning it focused on side effects and dosing, not on curing the disease. However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Jun 2014

An estimate. Start dates often move.

Expected to finish

Nov 2018

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy 2. Age up to 80 years 3. ECOG Performance Status of 0 or 1 4. Left ventricular ejection fraction =/\> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease 5. FEV1, FVC and DLCO =/\> 40%. No symptomatic pulmonary disease. 6. 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. 7. HIV negative 8. Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization 9. Patients or guardian able to sign informed consent 10. Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg) 11. Calculated GFR \> 50 ml/minute Exclusion Criteria: 1. Patients with uncontrolled hypertension (systolic \> 140, diastolic \> 90 despite antihypertensive therapy 2. Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms) 3. 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 4. Relapsed/refractory myeloma

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Conditions

The condition(s) this trial relates to.

plasma cell leukemia plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma Plasma cell leukemia

Contacts and locations

Locations

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.