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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00317811

Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study testing ascorbic acid, bortezomib and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Oncotherapeutics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ascorbic acid, bortezomib and melphalan
How many people
35 participants
Where
8 sitesUnited States
Study dates
Nov 2005to Feb 2009
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:

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Florida Cancer Specialists - Bonita Springs

    Bonita Springs, Florida, 34135

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Hematology-Oncology Medical Group of Fresno, Incorporated

    Fresno, California, 93720

  • Hematology Oncology Medical Group of Orange County, Incorporated

    Orange, California, 92868

  • Florida Oncology Associates

    Orange Park, Florida, 32073

  • Atlanta Cancer Care - Roswell

    Roswell, Georgia, 30076

  • Oncotherapeutics

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall response rate (combined complete response [CR], near CR, partial response [PR], and minimal response [MR]) and time to progression of disease in patients with newly diagnosed multiple myeloma treated with bortezomib, ascorbic acid, and melphalan.
  • Assess the safety and tolerability of this regimen in these patients.

Secondary

  • Assess the time to response in these patients.
  • Determine progression-free and overall survival of these patients.
  • Assess time to disease progression among subjects who continue to maintenance treatment with bortezomib.

OUTLINE: This is an open-label study.

  • Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral melphalan and oral ascorbic acid on days 1-4. Treatment repeats every 28 days to maximum response [MR] or for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive an additional 2 courses of induction therapy beyond MR and proceed to maintenance therapy. Patients with stable disease or without a maximum reduction in their paraprotein after 8 courses of induction therapy are eligible to receive maintenance therapy.
  • Maintenance therapy: Patients receive bortezomib IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Being tested
ascorbic acid, bortezomib, melphalan
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (complete response [CR], near CR, partial response, and minimal response)

  2. Safety and tolerability as assessed by NCI CTCAE v3.0

  3. Proportion of patients responding

  4. Time to disease progressionin patients receiving maintenance treatment

Secondary outcomes (4)

  1. Time to response

  2. Progression-free survival

  3. Overall survival as assessed by the Kaplan-Meier method

  4. Time to disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionFeb 2009

Resources

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
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317811
Sponsor's protocol ID
CDR0000479708
Other IDs
ONCOTHER-20052183, ONCOTHER-BAM2005, MILLENNIUM-ONCOTHER-20052183
Status last verified
Jun 2011
First submitted
24 Apr 2006
Last updated
6 Nov 2013
Results posted
No

Publications

  • Berenson 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.

    PubMed 19226361

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ascorbic acid, bortezomib and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Oncotherapeutics at 8 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: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Overall response rate (complete response [CR], near CR, partial response, and minimal response). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00317811, which also lists 1 linked publication.

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 6 Nov 2013.

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