Clinical trial · Interventional
Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
A Phase I/II Study of the Safety and Efficacy of Brostallicin (PNU-166196A) in Adult Patients With Multiple Myeloma That Has Progressed on Prior Chemotherapy
NCT00060203CI-TRIAL-00013487completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.
Conditions
Conditions (1)
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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brostallicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brostallicin
- interventionNames
- Drug: brostallicin
Primary outcomes (1)
- measure
- Objective Tumor Response Rate
- timeFrame
- 1 year
- description
- • Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma
Secondary outcomes (6)
- measure
- Maximum Tolerated Dose of brostallicin
- timeFrame
- 1 year
- measure
- Time to response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of multiple myeloma based on prior or current demonstration of the following criteria\*:
* Major criteria:
* Plasmacytoma on tissue biopsy
* Bone marrow plasmacytosis with at least 30% plasma cells
* Monoclonal globulin spike on serum electrophoresis exceeding 3.5 g/dL for IgG peaks or 2.0 g/dL for IgA peaks; greater than 1,000 mg/24hr of kappa or gamma light chain excretion on urine electrophoresis in the absence of amyloidosis
* Minor criteria:
* Bone marrow plasmacytosis with 10% to 30% plasma cells
* Monoclonal globulin spike present but less than levels in major criterion III above
* Lytic bone lesions
* Residual normal immunoglobulin M (IgM) no greater than 0.5 g/dL, IgA no greater than 0.1 g/dL, or IgG no greater than 0.6 g/dL NOTE: \*Diagnosis of multiple myeloma requires a minimum of 1 major and 1 minor criterion (I and a together is not sufficient; must be I and b, I and c, I and d; II and b, II and c, II and d; III and a, III and c, III and d) or 3 minor criteria that must include a and b (a, b, and c; a, b, and d)
* Measurable disease defined by 1 of the following values:
* Serum myeloma (M) protein (IgG or IgA) level greater than 1.0 g/dL
* Urine M protein (light chain disease) at least 300 mg/24hr
* Soft tissue plasmacytoma with bidimensional measurement at least 20 x 20 mm (10 x 10 mm if spiral CT scan is used)
* Must have progressed during or within 12 months of discontinuing prior myelosuppressive chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone (VAD) or melphalan) OR not responded after 2 courses of prior myelosuppressive chemotherapy
* No indolent or smoldering myeloma or localized plasmacytoma
* No known brain or leptomeningeal disease unless such lesions were previously irradiated, are currently not being treated with corticosteroids, and are associated with no clinical symptoms
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3 (at least 1,000/mm\^3 if neutropenia due to replacement of the normal bone marrow cells by myeloma cells)
* Platelet count at least 100,000/mm\^3 (at least 50,000/mm\^3 if thrombocytopenia due to replacement of the normal bone marrow cells by myeloma cells)
* Hemoglobin at least 8.0 g/dL (no transfusion allowed)
* No hyperviscosity syndrome
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal
* Creatinine no greater than 3.0 times ULN
* Calcium no greater than 12 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and sampling for study analysis
* HIV negative
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No AIDS-related illness
* No active infectious process or other severe concurrent disease that would make the patient inappropriate for study entry
* No mental incapacity or psychiatric illness that would preclude giving informed consent or completing follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* No concurrent anticancer biological response modifiers
* No concurrent immunotherapy
* No concurrent sargramostim (GM-CSF)
Chemotherapy
* See Disease Characteristics
* More than 2 years since prior high-dose chemotherapy with autologous bone marrow transplantation or stem cell support
* More than 4 weeks since prior myelosuppressive chemotherapy
* No other concurrent anticancer chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent anticancer hormonal therapy
* No concurrent chronic steroids
* Acute pulse dosing required for treatment of a concurrent medical condition is allowed, provided treatment duration is no greater than 2 weeks
* No concurrent corticosteroids (e.g., dexamethasone)
Radiotherapy
* More than 14 days since prior radiotherapy
* No prior radiotherapy to more than 25% of bone marrow
* No plans for radiotherapy within the next 6 months
* Concurrent palliative radiotherapy for skeletal pain allowed
Surgery
* More than 14 days since prior surgery
* No plans for surgery within the next 6 months
Other
* Acute toxic effects of prior therapy (except for alopecia and neurotoxicity) must have resolved to grade 0, 1, or the patient's baseline
* Treatment-related neurotoxicity must have resolved to the patient's baseline, not to exceed grade 2
* Chronic bisphosphonates for bone pain allowed only for maintenance doses
* More than 2 weeks since prior nonmyelosuppressive antimyeloma therapy
* More than 2 weeks since prior macrolide antibiotics
* No other concurrent investigational agents
* No concurrent macrolide antibiotics
* No concurrent participation in another treatment clinical studyReferences
Publications (0)
Data not yet available
No reference posted for this study.