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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.

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: 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
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

Other trials in United States

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.

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2003

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
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

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.

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