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HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA


OBJECTIVES: I. Assess bone marrow reconstitution and peripheral blood cell counts of
patients with multiple myeloma treated with high-dose melphalan (L-PAM) and total-body
irradiation (TBI) followed by peripheral blood stem cell (PBSC) rescue. II. Assess the
efficacy of intravenous L-PAM and TBI for treatment of relapsing/refractory myeloma. III.
Assess the tolerability and toxicity of this regimen in patients with relapsing multiple
myeloma. IV. Assess response rate and survival of relapsing/refractory patients treated with
this regimen.

OUTLINE: Prior to entry, patients will have received 3 monthly courses of standard VAD
followed by PBSC collection on Regimen A; those who responded to VAD continue standard VAD
to best response and upon relapse (on or off therapy) proceed to Regimen B. Patients with no
response to 3 courses of VAD and those with no response to an alkylating-based regimen
proceed immediately to Regimen B following PBSC collection. The following acronyms are used:
CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony Stimulating Factor (Amgen),
NSC-614629 L-PAM Melphalan, NSC-8806 PBSC Peripheral Blood Stem Cells VAD
Vincristine/Doxorubicin/Dexamethasone TBI Total Body Irradiation Regimen A: Stem Cell
Mobilization/Harvest. CTX; G-CSF. Regimen B: Single-Agent Myeloablative Chemoradiotherapy
with Stem Cell Rescue. L-PAM; TBI (Co60 or linear accelerators of 4 MV or greater); with
PBSC.

PROJECTED ACCRUAL: If 9 or fewer or 20 or more responses are seen in the first 50 patients
treated, the study will be discontinued.

Inclusion Criteria


DISEASE CHARACTERISTICS: Multiple myeloma confirmed by bone marrow plasmacytosis and with
measurable M-component in the serum or urine by immunoelectrophoresis or immunofixation No
Stage I myeloma No smoldering multiple myeloma Refractory to or in first relapse following
an initial response to VAD (vincristine/doxorubicin/dexamethasone), with relapse defined
as any of the following: 50% increase above the lowest remission level of serum or urine
M-protein while on therapy 25-50% increase above the lowest remission level of serum or
urine M-protein associated with either: Hypercalcemia (greater than 11 mg/dl) Hb decrease
of 2 g/dl attributable to increasing marrow plasmacytosis Appearance of new lytic lesions
Calcium no greater than 11 mg/dl No myeloma meningitis No plasma cell leukemia

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: ECOG 0-2 Hematopoietic: WBC
greater than 500 (after G-CSF) Platelets greater than 25,000 Hepatic: Bilirubin no greater
than 2.0 mg/dl Renal: Creatinine no greater than 2.0 mg/dl Cardiovascular: No NYHA class
II-IV disease Pulmonary: DLCO at least 50% of predicted FVC at least 75% of predicted FEV1
at least 60% of predicted Other: No uncontrolled infection No active fungal infection No
fever No prior malignancy within 5 years except: Basal cell skin cancer In situ carcinoma
of the cervix No pregnant or nursing women

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifiers allowed
Chemotherapy: No time limit between cytotoxic therapy and protocol treatment Prior
cumulative melphalan dose less than 300 mg Endocrine therapy: Corticosteroids for
hypercalcemia allowed Radiotherapy: Prior radiotherapy allowed Prior pelvic radiotherapy
allowed, but patients with such therapy are unlikely to have adequate PBSC harvested
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Morie A. Gertz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000064030

NCT ID:

NCT00002630

Start Date:

June 1993

Completion Date:

May 2001

Related Keywords:

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Mayo Clinic JacksonvilleJacksonville, Florida  32224