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Status:

TERMINATED

Study Comparing STR (Skeletal Targeted Radiotherapy) Plus Melphalan to Melphalan Alone, With Stem Cell Transplant in Multiple Myeloma

Lead Sponsor:

Poniard Pharmaceuticals

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18-70 years

Phase:

PHASE3

Brief Summary

STR (Skeletal Targeted Radiotherapy, 166Ho-DOTMP) is an investigational radiopharmaceutical that delivers radiation directly to cancer cells in the bone and bone marrow. Conventional methods of delive...

Detailed Description

PRIMARY OBJECTIVE: 1.To determine the efficacy of STR (166Ho-DOTMP). The primary endpoint of this study is to compare the CR rate at 6 months post-transplant (in the absence of further therapy) in su...

Eligibility Criteria

Inclusion

  • A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within four weeks prior to enrollment.
  • Subject must have primary refractory multiple myeloma defined as having failed to achieve an objective response (CR or PR using EBMT/IBMTR/ABMTR criteria) to any therapy since the initiation of induction therapy. At least one previous therapy must be a qualifying therapy that includes high dose pulsed steroids.
  • There must be \< 18 months from the beginning of induction therapy to time of enrollment on study.
  • Subject must meet institutional guidelines for autologous PBSCT.
  • Subject must have a minimum of 2 x 106 unmanipulated CD34+ cells/kg cryopreserved and available for transplant.
  • Age 18 and 70 years.
  • Adequate pulmonary function defined by FEV1, FVC and DLCO \> or = 50% of predicted.
  • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of \> or = 45%, with no evidence of cardiac amyloidosis.
  • Adequate liver function, defined as serum total bilirubin \< or = 2x institutional laboratory upper limit of normal and ALT/SGPT \< or = 3x institutional laboratory upper limit of normal.
  • Adequate renal function, defined as 24 hour measured creatinine clearance of \> or = 50 mL/min/1.73 m2 BSA and serum creatinine \< or = 1.8 mg/dL.
  • ECOG performance score (PS) of 0, 1, or 2.
  • Women of childbearing potential must have a negative pregnancy test (serum or urine beta HCG) and be using appropriate birth control methods.
  • Ability to understand the study and provide informed consent.

Exclusion

  • A subject meeting any of the following criteria is not eligible for participation in the study:
  • Non-secretory multiple myeloma.
  • Asymptomatic MGUS, smoldering multiple myeloma, or indolent multiple myeloma.
  • Solitary bone or extramedullary plasmacytoma.
  • Waldenstrom's macroglobulinemia (IgM myeloma).
  • Evidence of disease progression (such as new bone lesions) in the setting of a greater than 50% reduction in M-protein.
  • Absence of previous therapy with pulsed corticosteroids for multiple myeloma.
  • Previous high-dose therapy with stem cell or bone marrow transplant, including autologous, allogeneic, and reduced-intensity or non-myeloablative allogeneic transplants.
  • Life expectancy severely limited by concomitant illness (less than 6 months).
  • Evidence of symptomatic spinal cord compression or pathological fracture within 3 months.
  • Cumulative external beam radiation to \> 20% of marrow volume or \> 40 Gy to any single region of the spinal cord.
  • Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney or the bladder.
  • Uncontrolled arrhythmia or symptomatic cardiac disease.
  • Clinical evidence of amyloidosis involving the heart, lungs, liver, kidney, autonomic nervous system, or GI tract.
  • History of hemorrhagic cystitis.
  • Current microscopic or gross hematuria in the absence of vaginal bleeding.
  • Obstructive uropathy.
  • Inability to have bladder catheter placed.
  • Evidence of HIV-seropositivity.
  • Recent history of alcohol or drug abuse.
  • History of non-compliance in other studies.
  • Use of bisphosphonates within 14 days preceding enrollment.
  • Use of any other therapy for multiple myeloma (including standard, induction, investigational, and alternative therapies) within 4 weeks prior to enrollment.
  • Experimental therapies for any other conditions in the four weeks prior to enrollment.
  • Pregnant or lactating women.
  • Known allergy to vitamin C or bisphosphonates.
  • Other prior malignancy except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease-free for 5 years.

Key Trial Info

Start Date :

March 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00083564

Start Date

March 1 2004

Last Update

March 31 2009

Active Locations (21)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (21 locations)

1

University of Alabama

Birmingham, Alabama, United States, 35249

2

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868

3

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

4

University of Miami

Miami, Florida, United States, 33136