Clinical trial · Interventional
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn by PI
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Leukemia | Plasma Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bendamustine 200 mg/m2
- description
- Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
- interventionNames
- Drug: Bendamustine
- type
- EXPERIMENTAL
- label
- Bendamustine 250 mg/m2
- description
- Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).
- interventionNames
- Drug: Bendamustine
Primary outcomes (1)
- measure
- Maximum tolerated dose of bendamustine
- timeFrame
- 2 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available