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A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Refractory Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine


PRIMARY OBJECTIVES:

I. Compare the complete response (CR) and near CR rate in patients undergoing autologous
stem cell transplant (ASCT) using melphalan 280 mg/m^2 or melphalan 200 mg/m^2.

SECONDARY OBJECTIVES:

I. Compare toxicities between patients receiving amifostine and melphalan 280 mg/m^2 or
melphalan 200 mg/m^2.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

INDUCTION THERAPY:

ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV)
over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on
day 2.

ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and
melphalan as in arm I at a lower dose.

AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20
hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day
0.

Patients undergo restaging of the disease between days 80-90. Patients with progressive
disease are removed from the study. Patients who achieve a CR or near-CR can proceed to
optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo
additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.

Patients again undergo restaging of the disease 80-90 days later. Patients with progressive
disease are removed from the study. Patients without progressive disease can proceed to
maintenance therapy.

After completion of study treatment, patients are followed up every 3 months for 5 years.


Inclusion Criteria:



- Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation

- Patients must meet Salmon and Durie criteria for initial diagnosis of MM

- Transplant will be offered to patients with stage II or III MM

- Measurable disease, defined as serum monoclonal protein >= 0.2 g/dl or Bence Jones
protein >= 200 mg/24 h

- Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2

- Life expectancy is not severely limited by concomitant illness

- Left ventricular ejection fraction >= 50%

- No uncontrolled arrhythmias or symptomatic cardiac disease

- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and
diffusion capacity of carbon monoxide (DLCO) >= 50%

- No symptomatic pulmonary disease

- Human immunodeficiency virus (HIV) negative

- Bilirubin < 2 mg/dl

- Serum glutamic pyruvate transaminase (SGPT) < 2.5 x normal

- Creatinine clearance >= 60 cc/min, estimated or measured

- Signed informed consent

Exclusion Criteria:

- Pregnant or lactating females

- Uncontrolled infection

- Planned tandem autologous/reduced intensity allograft

- Insufficient PBSC for an autologous transplant (< 3.0 x 10^6 CD34+ cells/kg total)

- Prior autologous transplant

- Non-secretory myeloma and patients who are in a complete response or near complete
response after conventional therapy

- Patients unwilling to practice adequate forms of contraception if clinically
indicated

- Male patients on study need to be consulted to use latex condoms, even if they have
had a vasectomy, every time they have sex with a woman who is able to have children

- Patients with history of seizures

- Patients receiving antihypertensive therapy that cannot be stopped for 24 hours
preceding amifostine treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR and near CR rates

Outcome Description:

Observe a statistically significant difference at the two-sided significance level of .05 with 80% and 90% power for various assumed-true CR rates.

Outcome Time Frame:

Up to 120 days after transplant

Safety Issue:

No

Principal Investigator

William Bensinger

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

2004.00

NCT ID:

NCT00217438

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Cedars-Sinai Medical CenterLos Angeles, California  90048
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
VA Puget Sound Health Care SystemSeattle, Washington  98101
University of RochesterRochester, New York  14642