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.
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
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm, Pain
- What is being tested?
- Pamidronate, Zoledronic acid and Sm 153 lexidronam
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm, Pain
- 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 group | Role | What they receive |
|---|---|---|
| Sm 153 lexidronam | Experimental | Not 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.
Toxicity (Phase I)
Measured: 12 weeks
Confirmed clinical response of serum and urine monoclonal protein (Phase II)
Measured: 12 weeks
Secondary outcomes (3)
Response (Phase I)
Measured: 12 weeks
Bone pain response (Phase II)
Measured: 12 weeks
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.
- First posted5 Jun 2007 (estimated)
- Study start21 Mar 2005
- Primary completion22 May 2007
- Study completion2 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Angela Dispenzieri, M.D., Study chair, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
- ClinicalTrials.gov ID
- NCT00482378
- Acronym / sponsor ID
- CDR0000546769
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm, Pain
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Mar 2005 (actual)
- Primary completion
- 22 May 2007 (actual)
- Study completion
- 2 Dec 2008 (actual)
- First posted
- 5 Jun 2007 (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: 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sm 153 lexidronam | Experimental | Drug: Pamidronate, Drug: Zoledronic acid, Radiation: Sm 153 lexidronam |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| PamidronateAlso: Aredia90 mg by IV monthly. | Drug | Sm 153 lexidronam |
| Zoledronic acidAlso: Zometa4 mg by IV monthly. | Drug | Sm 153 lexidronam |
| Sm 153 lexidronamAlso: Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).0.5 mCi/kg or 1 mCi/kg by IV. | Radiation | Sm 153 lexidronam |
Primary outcome
Toxicity (Phase I)
Time frame: 12 weeks
Confirmed clinical response of serum and urine monoclonal protein (Phase II)
Time frame: 12 weeks
3 secondary outcomes
Response (Phase I)
Time frame: 12 weeks
Bone pain response (Phase II)
Time frame: 12 weeks
Toxicity (Phase II)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Angela Dispenzieri, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
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.