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Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00482378

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

A Phase 1/2 study testing Pamidronate, Zoledronic acid and Sm 153 lexidronam in people with Multiple Myeloma and Plasma Cell Neoplasm and Pain, run by Mayo Clinic at 1 site 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. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
Pamidronate, Zoledronic acid and Sm 153 lexidronam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
21 Mar 2005to 2 Dec 2008
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • Relapsed or refractory disease, meeting 1 of the following criteria:
  • Recurrent disease after stem cell transplantation
  • Recurrent or progressive disease despite treatment with ≥ 1 standard regimen (e.g., an alkylating agent plus glucocorticoid and/or the combination of vincristine, doxorubicin hydrochloride, and dexamethasone)
  • Measurable or evaluable disease, defined by at least 1 of the following:
  • Monoclonal protein ≥ 1.0 g by serum 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)
  • Patients must have already undergone hematopoietic stem cell collection, if believed to be a transplant candidate OR not eligible for a hematopoietic stem cell transplant

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
  • ANC ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
  • 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 active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
  • No uncontrolled infection
  • No other co-morbidity that would interfere with the patient's ability to participate in this trial
  • No known hypersensitivity to any of the components of samarium Sm 153 lexidronam pentasodium or bisphosphonates

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior surgery, radiotherapy, or other antineoplastic therapy
  • More than 4 weeks since prior melphalan or other myelosuppressive agents
  • More than 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
  • More than 30 days since prior and no other concurrent investigational therapy
  • No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89
  • No concurrent external beam radiotherapy
  • No concurrent high-dose corticosteroids
  • Concurrent chronic steroids (maximum dose of 20 mg/day prednisone equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis)
  • Low-dose steroids allowed for replacement or inhalation therapy
  • No other concurrent medications, including any of the following:
  • Cytotoxic chemotherapy
  • Systemic antineoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
  • Prophylactic hematopoietic growth factors
  • Hematopoietic growth factors allowed for established cytopenia therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain. (Phase I)
  • Determine the clinical response in patients treated with these regimens. (Phase II)

Secondary

  • Determine the effect of these regimens on changes in patient-reported bone pain levels.

OUTLINE: This is a multicenter, open-label, pilot, phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.

  • Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1. Patients also receive zoledronic acid IV over 15 minutes or pamidronate disodium IV over 2-4 hours on day 1 and then monthly thereafter in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium 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 at the MTD determined in phase I and zoledronic acid or pamidronate disodium as in phase I.

Bone pain is assessed periodically.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Being tested
Pamidronate, Zoledronic acid, Sm 153 lexidronam
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, pain
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Pain

What participants receive

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

  • PamidronateDrug

    Also called Aredia

    90 mg by IV monthly.

  • Zoledronic acidDrug

    Also called Zometa

    4 mg by IV monthly.

  • Sm 153 lexidronamRadiation

    Also called Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).

    0.5 mCi/kg or 1 mCi/kg by IV.

Study groups in NCT00482378
Study groupRoleWhat they receive
Sm 153 lexidronamExperimentalNot described
Receives: Drug: Pamidronate; Drug: Zoledronic acid; Radiation: Sm 153 lexidronam

What is being measured

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

  1. Toxicity (Phase I)

    Measured: 12 weeks

  2. Confirmed clinical response of serum and urine monoclonal protein (Phase II)

    Measured: 12 weeks

Secondary outcomes (3)
  1. Response (Phase I)

    Measured: 12 weeks

  2. Bone pain response (Phase II)

    Measured: 12 weeks

  3. Toxicity (Phase II)

    Measured: 12 weeks

Timeline

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

  1. First posted5 Jun 2007 (estimated)
  2. Study start21 Mar 2005
  3. Primary completion22 May 2007
  4. Study completion2 Dec 2008

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482378
Sponsor's protocol ID
CDR0000546769
Other IDs
P30CA015083, MC048B, 261-05
Status last verified
Aug 2018
First submitted
4 Jun 2007
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pamidronate, Zoledronic acid and Sm 153 lexidronam in people with Multiple Myeloma and Plasma Cell Neoplasm and Pain, run by Mayo Clinic at 1 site 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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) (time frame: 12 weeks). 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 14 Aug 2018.

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