Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00045136
Chemotherapy, Holmium Ho 166 DOTMP, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
A Phase 1/2 study testing melphalan, peripheral blood stem cell transplantation and holmium Ho 166 DOTMP in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Poniard Pharmaceuticals at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- melphalan, peripheral blood stem cell transplantation and holmium Ho 166 DOTMP
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Jan 2002to Jan 2003
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma (MM)
- Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the criteria for diagnosis of MM
- No non-secretory MM
- No symptomatic MGUS, smoldering MM, or indolent MM
- No solitary bone or extramedullary plasmacytoma
- No immunoglobulin M myeloma
- Prior induction therapy for myeloma required
- Responding, stable, or progressive disease after induction therapy, or relapsed disease
- Candidate for autologous hematopoietic stem cell transplantation
- Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures
- Availability of at least 2,000,000 CD34+ cells/kg
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2 mg/dL
- SGPT no greater than 2 times upper limit of normal
- No clinical evidence of amyloidosis of the liver
Renal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 45 mL/min
- Renal ultrasound normal
- No clinical evidence of amyloidosis of the kidney
- No urinary obstruction in the renal pelvis, ureter, or bladder outlet by ultrasound
Cardiovascular
- Ejection fraction at least 50% with no evidence of amyloidosis by echocardiogram
- No clinical evidence of amyloidosis of the heart
- No uncontrolled arrhythmia
- No symptomatic cardiac disease
Pulmonary
- FEV1, FVC, and DLCO at least 60%
- No symptomatic pulmonary disease
- No clinical evidence of amyloidosis of the lungs
Other
- No known allergy to vitamin C or bisphosphonates
- No known hypersensitivity to technetium Tc 99m phosphorus radiopharmaceuticals (e.g., technetium Tc 99m-methylene diphosphonate)
- No concurrent illness that would severely limit life expectancy
- No symptoms, physical findings, or radiographic evidence of cord compression
- No clinical evidence of amyloidosis of the autonomic nervous system or gastrointestinal tract
- No prior noncompliance in other studies
- No other malignancy within the past 5 years except treated indolent skin cancers or carcinoma in situ of the cervix
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior stem cell or bone marrow transplantation
- No concurrent maintenance therapy comprising interferon or thalidomide
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- See Disease Characteristics
- No concurrent maintenance therapy comprising dexamethasone
Radiotherapy
- No prior cumulative external-beam radiotherapy (EBRT) to more than 20% of bone marrow
- No prior cumulative EBRT dose of 30 Gy or more to the spinal cord
- No prior radiotherapy to the bladder
Surgery
- See Disease Characteristics
Other
- At least 4 weeks since prior investigational agents for MM
- At least 4 weeks since other prior experimental therapies for any other condition
- No bisphosphonates for at least 4 weeks before study, during study, and for at least 30 days posttransplantation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-0006
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
University of California Davis Cancer Center
Sacramento, California, 95817
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
Read the detailed description
OBJECTIVES:
- Determine the radiation absorbed dose of holmium Ho 166 DOTMP to the kidney in patients with multiple myeloma, based on whole body gamma camera image data for comparison with that obtained using an ICRP mathematical model.
- Determine the average marrow dose of this drug in these patients using gamma camera whole body counts in patients receiving this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Compare marrow dose estimates determined from gamma camera whole-body counts and thyroid uptake probe counts in patients receiving this drug.
- Evaluate intra-patient variability of the uptake of this drug in the bone with repeat tests.
- Determine whether the biodistribution and dosimetry is influenced by administering this drug as a bolus compared to a 15-minute infusion in these patients.
- Compare the reduction in dose rate from the 15-minute infusion vs the bolus injection of this drug to estimate the effect on kidney exposure in these patients.
- Determine the renal transit time for each patient after bolus injection of this drug and assess whether this information improves the dose estimate to kidney with the mathematical model.
- Determine whether there is correlation of renal transit time from technetium Tc 99m-diethylenetriaminepentaacetic acid (DTPA) with holmium Ho 166 DOTMP.
- Determine the adverse events in patients receiving this drug.
- Determine the efficacy of a targeted therapy dose of holmium Ho 166 DOTMP with melphalan followed by autologous peripheral blood stem cell transplantation in these patients.
OUTLINE: This is a multicenter study. Patients are entered into one of two cohorts.
- Cohort A: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on day 1 and then IV bolus on day 8.
- Cohort B: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on days 1 and 8.
After each diagnostic dose, patients in both cohorts also undergo gamma camera imaging of the whole body on days 1 and 8.
Approximately 1-3 weeks later, patients in both cohorts who demonstrate adequate uptake of the first diagnostic dose of holmium Ho 166 DOTMP into the bone marrow then receive therapeutic holmium Ho 166 DOTMP IV over 15 minutes once between days -13 to -10 followed by melphalan IV over 20-30 minutes once between days -10 to -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
Patients are followed monthly for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A minimum of 12 patients (6 per cohort) will be accrued for this study.
- Being tested
- melphalan, peripheral blood stem cell transplantation, holmium Ho 166 DOTMP
- Keywords
- refractory multiple myeloma, 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.
melphalanDrug
peripheral blood stem cell transplantationProcedure or surgery
holmium Ho 166 DOTMPRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionJan 2003
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.
- 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
Sponsor and investigators
- Lead sponsor
- Poniard Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wendy Jenkins, Principal investigator, Poniard Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045136
- Sponsor's protocol ID
- CDR0000256377
- Other IDs
- PONIARD-0102, NEORX-0102, FHCRC-1704.00
- Status last verified
- Apr 2009
- First submitted
- 6 Sep 2002
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Dosimetry Trial to Evaluate Radiation Absorbed Dose From Holmium-166-DOTMP in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00045136
- Acronym / sponsor ID
- CDR0000256377
- Keywords
- refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poniard PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jan 2003 (actual)
- First posted
- 27 Jan 2003 (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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Holmium Ho 166 DOTMP may deliver radiation directly to cancer cells and cause less damage to normal tissue. Combining chemotherapy and holmium Ho 166 DOTMP with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and holmium Ho 166 DOTMP and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining holmium Ho 166 DOTMP with melphalan and peripheral stem cell transplantation in treating patients who have multiple myeloma.
Detailed description
OBJECTIVES:
- Determine the radiation absorbed dose of holmium Ho 166 DOTMP to the kidney in patients with multiple myeloma, based on whole body gamma camera image data for comparison with that obtained using an ICRP mathematical model.
- Determine the average marrow dose of this drug in these patients using gamma camera whole body counts in patients receiving this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Compare marrow dose estimates determined from gamma camera whole-body counts and thyroid uptake probe counts in patients receiving this drug.
- Evaluate intra-patient variability of the uptake of this drug in the bone with repeat tests.
- Determine whether the biodistribution and dosimetry is influenced by administering this drug as a bolus compared to a 15-minute infusion in these patients.
- Compare the reduction in dose rate from the 15-minute infusion vs the bolus injection of this drug to estimate the effect on kidney exposure in these patients.
- Determine the renal transit time for each patient after bolus injection of this drug and assess whether this information improves the dose estimate to kidney with the mathematical model.
- Determine whether there is correlation of renal transit time from technetium Tc 99m-diethylenetriaminepentaacetic acid (DTPA) with holmium Ho 166 DOTMP.
- Determine the adverse events in patients receiving this drug.
- Determine the efficacy of a targeted therapy dose of holmium Ho 166 DOTMP with melphalan followed by autologous peripheral blood stem cell transplantation in these patients.
OUTLINE: This is a multicenter study. Patients are entered into one of two cohorts.
- Cohort A: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on day 1 and then IV bolus on day 8.
- Cohort B: Patients receive a diagnostic dose of holmium Ho 166 DOTMP IV over 15 minutes on days 1 and 8.
After each diagnostic dose, patients in both cohorts also undergo gamma camera imaging of the whole body on days 1 and 8.
Approximately 1-3 weeks later, patients in both cohorts who demonstrate adequate uptake of the first diagnostic dose of holmium Ho 166 DOTMP into the bone marrow then receive therapeutic holmium Ho 166 DOTMP IV over 15 minutes once between days -13 to -10 followed by melphalan IV over 20-30 minutes once between days -10 to -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
Patients are followed monthly for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A minimum of 12 patients (6 per cohort) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 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 |
|---|---|---|
| melphalan | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| holmium Ho 166 DOTMP | Radiation | – |
Primary outcome
Not reported in the source record.
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 3 Apr 2009.
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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.
Wendy Jenkins principal investigator
Poniard Pharmaceuticals
5 sites 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 melphalan, peripheral blood stem cell transplantation and holmium Ho 166 DOTMP in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Poniard Pharmaceuticals at 5 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 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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 3 Apr 2009.