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Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00006466

Beta Alethine in Treating Patients With Myeloma

A Phase 1/2 study testing beta alethine in people with Multiple Myeloma and Plasma Cell Neoplasm and Precancerous Condition, run by LifeTime Pharmaceuticals at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have myeloma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
beta alethine
How many people
Not given
Where
3 sitesUnited States
Study dates
Aug 2000to not given
Phase
Phase 1/2
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:

  • Histologically proven myeloma
  • Multiple myeloma
  • Indolent myeloma with slowly progressive bone pathology
  • Smoldering myeloma with no bone pathology but a progressive increase in M-protein
  • Solitary myeloma OR
  • Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level
  • Measurable M-protein or Bence Jones protein
  • Indolent disease not requiring therapy allowed
  • No clinical signs or evidence of active brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • At least 4 months

Hematopoietic:

  • See Disease Characteristics
  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No acute changes on electrocardiogram
  • No uncontrolled angina, heart failure, or arrhythmia

Other:

  • Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)
  • HIV negative
  • No AIDS
  • No active bacterial infection (e.g., abscess) or with fistula
  • No history of alcoholism, drug addiction, or psychotic disorders that would preclude study
  • No other nonmalignant disease that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy or cytokines

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • No prior radiotherapy to greater than 25% of bone marrow

Surgery:

  • Recovered from any prior surgery
  • No prior solid organ transplantation

Other:

  • No other concurrent investigational agent
  • No concurrent immunosuppressive agents
  • No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Emory Clinic

    Atlanta, Georgia, 30322

  • St. Vincents Comprehensive Cancer Center

    New York, New York, 10011

  • Victory Over Cancer

    Rockville, Maryland, 20852

Other trials in United States

About this study

Official title: Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma

RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have myeloma.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance.
  • Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive beta alethine subcutaneously every 2 weeks for 6 doses. At day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. Patients with an apparent complete response receive additional courses.

Patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.

Being tested
beta alethine
Keywords
monoclonal gammopathy of undetermined significance, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Monoclonal Gammopathy of Undetermined Significance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • beta alethineDrug

Timeline

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

  1. First posted8 Oct 2003 (estimated)
  2. Study startAug 2000

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 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006466
Sponsor's protocol ID
CDR0000068280
Other IDs
LIFETIME-LTP-99-01, LIFETIME-IRB-0300203
Status last verified
Sep 2002
First submitted
6 Nov 2000
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing beta alethine in people with Multiple Myeloma and Plasma Cell Neoplasm and Precancerous Condition, run by LifeTime Pharmaceuticals at 3 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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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 18 Dec 2013.

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