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A Phase I/II Study of 153 Sm EDTMP (Quadramet™) and PS-341 (Velcade®) in Patients With Relapsed or Refractory Multiple Myeloma

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase I/II Study of 153 Sm EDTMP (Quadramet™) and PS-341 (Velcade®) in Patients With Relapsed or Refractory Multiple Myeloma



- Determine the maximum tolerated dose of bortezomib when given together with samarium Sm
153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma.
(Phase I)

- Determine the safety and tolerability of this regimen in these patients. (Phase II)

- Determine the hematologic response rate in patients treated with this regimen. (Phase


- Determine the rate of serum immunoglobulin light chain reduction in patients treated
with this regimen.

- Assess the in vivo toxicity of this regimen to the progenitor cells by measuring
complete blood cell count and micronucleated reticulocyte count in these patients.

OUTLINE: This is a phase I, pilot, open-label, dose-escalation study of bortezomib followed
by a phase II study.

- Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on
day 1 and bortezomib IV over 3-5 seconds on days 2 and 5.

Cohorts of 3-6 patients receive escalating doses of bortezomib 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 as in phase I and
bortezomib at the MTD determined in phase I .

Patients undergo blood sample collection at baseline and then on days 1-6 for correlative
studies. Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free
light chain ratio to determine the early effects of treatment.

After completion of study treatment, patients are followed weekly for 7 weeks, monthly for 3
months and then every 3 months for a total of 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of multiple myeloma

- Relapsed or refractory disease

- Measurable or evaluable disease as defined by at least 1 of the following:

- Serum monoclonal protein ≥ 1.0 g by 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)

- Previously treated disease

- No limit to prior therapy provided there is adequate residual organ function

- Must have undergone hematopoietic stem cell collection (for transplant candidates) OR
not considered to be a hematopoietic stem cell transplant candidate


- ECOG performance status (PS) 0-2 (ECOG PS of 3 allowed if secondary only to pain)

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

- ANC ≥ 1,000/mm^3

- 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 other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the
cervix, or breast cancer

- No uncontrolled infection

- No known hypersensitivity to any of the components of study drugs

- No other co-morbidity that would preclude study participation


- Recovered from prior surgery, radiotherapy, or other antineoplastic therapy

- No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89

- At least 3 weeks since prior myelosuppressive agents

- At least 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide)

- At least 2 weeks since prior and no concurrent high-dose corticosteroids

- Chronic steroids (maximum dose of 20 mg/day prednisone or equivalent) allowed
for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid

- At least 30 days since prior and no other concurrent investigational therapy

- No concurrent external beam radiotherapy

- No concurrent cytotoxic chemotherapy

- No other concurrent systemic antineoplastic therapy including, but not limited to,
any of the following:

- Immunotherapy

- Hormonal therapy

- Monoclonal antibody therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity (Phase I)

Safety Issue:


Principal Investigator

Angela Dispenzieri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

June 2009

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905