Stage II Multiple MyelomaPhase 2NCT00085345
Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing arsenic trioxide, ascorbic acid and melphalan in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by Oncotherapeutics at 19 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
- What is being tested?
- arsenic trioxide, ascorbic acid and melphalan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 19 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma meeting at least 1 of the following criteria:
- Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy
- Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids
- 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
- No non-secretory myeloma
- No plasma cell leukemia
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1,000/mm^3
- Pancytopenia secondary to multiple myeloma or hypersplenism allowed
Hepatic
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 2 times ULN (unless clearly related to disease)
- No known active hepatitis B or C infection
Renal
- Calcium < 14 mg/dL
Cardiovascular
- No evidence of acute ischemia or new conduction system abnormality by electrocardiogram
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart failure
- No poorly controlled hypertension
- No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L
Other
- No active infection
- No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- No diabetes mellitus
- No other serious medical or psychiatric illness that would preclude study participation
- No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
- No history of grand mal seizures
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy or antibody therapy
Chemotherapy
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
- See Disease Characteristics
- No other concurrent corticosteroids
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- More than 4 weeks since prior major surgery
Other
- No other concurrent investigational agents
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309-0633
Center for Cancer and Blood Disorders at Suburban Hospital
Bethesda, Maryland, 20817
Southbay Oncology / Hematology Medical Group
Campbell, California, 95008
Study site
Fountain Valley, California, 92708
Hematology-Oncology Medical Group of Fresno, Incorporated
Fresno, California, 93720
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
Miami Beach, Florida, 33140
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112-2699
Hematology Oncology Medical Group of Orange County, Incorporated
Orange, California, 92868
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Cancer Care Associates Medical Group - Redondo Beach
Redondo Beach, California, 90277
Atlanta Cancer Care - Roswell
Roswell, Georgia, 30076
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Utah Cancer Specialists - Administrative Office
Salt Lake City, Utah, 84106
Redwood Regional Oncology Center - Sotoyome
Santa Rosa, California, 95405
Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
Soquel, California, 95073
San Diego Cancer Center - Vista
Vista, California, 92083
Oncotherapeutics
West Hollywood, California, 90069
About this study
Official title: Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
- Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the time to response and overall survival of patients treated with this regimen.
- Determine the effects of this regimen on renal failure associated with MM in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
- Being tested
- arsenic trioxide, ascorbic acid, melphalan, chemosensitization/potentiation, chemotherapy
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
ascorbic acidDrug
melphalanDrug
chemosensitization/potentiationProcedure or surgery
chemotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II 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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James R. Berenson, MD, Study chair, Oncotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085345
- Sponsor's protocol ID
- ONCOTHER-MAC001
- Other IDs
- CDR0000368637
- Status last verified
- Jul 2006
- First submitted
- 10 Jun 2004
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00085345
- Acronym / sponsor ID
- ONCOTHER-MAC001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OncotherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 11 Jun 2004 (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.
RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
- Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the time to response and overall survival of patients treated with this regimen.
- Determine the effects of this regimen on renal failure associated with MM in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| arsenic trioxide | Drug | – |
| ascorbic acid | Drug | – |
| melphalan | Drug | – |
| chemosensitization/potentiation | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 10 Jul 2013.
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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.
James R. Berenson, MD study chair
Oncotherapeutics
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arsenic trioxide, ascorbic acid and melphalan in people with Stage II Multiple Myeloma and Stage III Multiple Myeloma, run by Oncotherapeutics at 19 sites 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?
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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 10 Jul 2013.