Clinical trial · Interventional
Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
- 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: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic acid and melphalan works in treating patients with newly diagnosed 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ascorbic acid | Dietary Supplement | — | UNRESOLVED |
| bortezomib | Drug | Bortezomib | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Overall response rate (complete response [CR], near CR, partial response, and minimal response)
- measure
- Safety and tolerability as assessed by NCI CTCAE v3.0
- measure
- Proportion of patients responding
- measure
- Time to disease progressionin patients receiving maintenance treatment
Secondary outcomes (4)
- measure
- Time to response
- measure
- Progression-free survival
- measure
- Overall survival as assessed by the Kaplan-Meier method
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed symptomatic multiple myeloma based on the following criteria: * Durie-Salmon staging * Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours * Symptomatic disease * No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\], and skin changes) * No plasma cell leukemia PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy \> 3 months * Platelet count ≥ 50,000/mm³ (30,000/mm³ if the bone marrow is extensively infiltrated) * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1,000/mm³ * Creatinine ≤ 3 mg/dL * Sodium \> 130 mmol/L corrected * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 2 times ULN unless clearly related to the disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Any ECG abnormality has to be documented by the investigator as not medically relevant * No electrocardiographic evidence of acute ischemia or new conduction system abnormalities * No myocardial infarction or EKG evidence of infarction within the past 6 months * No active infection * No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL \[3.5 mmol/L\]) * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No active conduction system abnormalities * No poorly controlled hypertension * No diabetes mellitus * No known HIV infection * No known active hepatitis B or C viral infection * No history of grand mal seizures * No history of allergic reaction to compounds of similar chemical or biological composition to melphalan, bortezomib, boron, or mannitol * No peripheral neuropathy ≥ grade 2 within the past 14 days * No other serious medical or psychiatric illness that could potentially interfere with the completion of study treatment PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy * More than 4 weeks since prior major surgery * No prior therapy for myeloma * Prior prednisone at a total of 400mg over ≤ 4 days (or an equivalent potency of another steroid) allowed * No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent) * No other concurrent investigational agents * No other concurrent antimyeloma therapy
References
Publications (1)
- RESULTBerenson JR, Yellin O, Woytowitz D, Flam MS, Cartmell A, Patel R, Duvivier H, Nassir Y, Eades B, Abaya CD, Hilger J, Swift RA. Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well-tolerated frontline regimen. Eur J Haematol. 2009 Jun;82(6):433-9. doi: 10.1111/j.1600-0609.2009.01244.x. Epub 2009 Feb 17. PMID 19226361