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Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00478075

Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing bortezomib, immunologic technique and samarium Sm 153 lexidronam pentasodium in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 3 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: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, immunologic technique and samarium Sm 153 lexidronam pentasodium
Type of treatment
Surgery or procedure
How many people
50 participants
Where
3 sitesUnited States
Study dates
Sep 2005to Jun 2009
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:

  • Diagnosis of multiple myeloma
  • Relapsed or refractory disease
  • Measurable or evaluable disease as defined by at least 1 of the following:
  • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
  • Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis
  • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
  • Previously treated disease
  • No limit to prior therapy provided there is adequate residual organ function
  • Must have undergone hematopoietic stem cell collection (for transplant candidates) OR not considered to be a hematopoietic stem cell transplant candidate

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 (ECOG PS of 3 allowed if secondary only to pain)
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • ANC ≥ 1,000/mm^3
  • Creatinine ≤ 3 mg/dL
  • Calcium ≤ 15 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
  • No impending long bone fracture
  • No other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or breast cancer
  • No uncontrolled infection
  • No known hypersensitivity to any of the components of study drugs
  • No other co-morbidity that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • Recovered from prior surgery, radiotherapy, or other antineoplastic therapy
  • No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89
  • At least 3 weeks since prior myelosuppressive agents
  • At least 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide)
  • At least 2 weeks since prior and no concurrent high-dose corticosteroids
  • Chronic steroids (maximum dose of 20 mg/day prednisone or equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis)
  • At least 30 days since prior and no other concurrent investigational therapy
  • No concurrent external beam radiotherapy
  • No concurrent cytotoxic chemotherapy
  • No other concurrent systemic antineoplastic therapy including, but not limited to, any of the following:
  • Immunotherapy
  • Hormonal therapy
  • Monoclonal antibody therapy

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

Other trials in United States

About this study

Official title: A Phase I/II Study of 153 Sm EDTMP (Quadramet™) and PS-341 (Velcade®) in Patients With Relapsed or Refractory Multiple Myeloma

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma. (Phase I)
  • Determine the safety and tolerability of this regimen in these patients. (Phase II)
  • Determine the hematologic response rate in patients treated with this regimen. (Phase II)

Secondary

  • Determine the rate of serum immunoglobulin light chain reduction in patients treated with this regimen.
  • Assess the in vivo toxicity of this regimen to the progenitor cells by measuring complete blood cell count and micronucleated reticulocyte count in these patients.

OUTLINE: This is a phase I, pilot, open-label, dose-escalation study of bortezomib followed by a phase II study.

  • Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 and bortezomib IV over 3-5 seconds on days 2 and 5.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

  • Phase II: Patients receive samarium Sm 153 lexidronam pentasodium as in phase I and bortezomib at the MTD determined in phase I .

Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies. Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment.

After completion of study treatment, patients are followed weekly for 7 weeks, monthly for 3 months and then every 3 months for a total of 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Being tested
bortezomib, immunologic technique, samarium Sm 153 lexidronam pentasodium
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory 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.

  • bortezomibDrug

  • immunologic techniqueOther

  • samarium Sm 153 lexidronam pentasodiumRadiation

What is being measured

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

  1. Toxicity (Phase I)

  2. Confirmed clinical response (complete response, very good partial response, partial response, or minimal response) (Phase II)

Secondary outcomes (2)
  1. Immunoglobulin free light chain response

  2. Changes in complete blood cell count and micronucleated reticulocyte count

Timeline

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

  1. First posted24 May 2007 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2007
  4. Study completionJun 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 1/2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478075
Sponsor's protocol ID
CDR0000546736
Other IDs
P30CA015083, MC0585, 1586-05
Status last verified
May 2011
First submitted
23 May 2007
Last updated
11 May 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bortezomib, immunologic technique and samarium Sm 153 lexidronam pentasodium in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic 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: finished, as of the sponsor's last update on 11 May 2011. 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?

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?

Toxicity (Phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

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 11 May 2011.

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