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Allogeneic Stem Cell Transplantation For Multiple Myeloma: A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI

Phase 1/Phase 2
65 Years
Open (Enrolling)
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

Allogeneic Stem Cell Transplantation For Multiple Myeloma: A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI


I. To evaluate engraftment of human leukocyte antigen (HLA) identical peripheral blood stem
cell (PBSC) allografts given after conditioning with total-body irradiation (TBI) (200 cGy)
and post-grafting immunosuppression with cyclosporine (CSP)/mycophenolate mofetil (MMF) in
myeloma patients initially cytoreduced with high-dose melphalan.

II. To evaluate non-relapse mortality at day 100 post allografting. III. To evaluate the
efficacy of this allografting strategy in terms of long-term progression free survival


CONDITIONING REGIMEN: Patients receive high-dose melphalan intravenously (IV) over 15-20
minutes on day -2.

TRANSPLANTATION: Patients undergo autologous bone marrow or PBSC transplantation (PBSCT) on
day 0.

NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant,
patients undergo TBI on day 0.

TRANSPLANTATION: Patients undergo donor PBSCT on day 0.

IMMUNOSUPPRESSION: Patients receive cyclosporine IV twice daily (BID) on days -1 and 0 and
orally (PO) BID on days 1-80 with taper based on evaluation of disease response and
graft-versus-host disease (GVHD). Patients also receive mycophenolate mofetil PO BID on days

immunosuppression, patients achieving persistent or progressive disease may undergo DLI over
30 minutes every 4 weeks for up to 3 treatments.

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

Inclusion Criteria:

- Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant
will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis
or have received chemotherapy and/or radiation therapy for progressive MM after
initial diagnosis of stage I disease

- The patient must have the capacity to give informed consent

- Have received at least 4 cycles of conventional dose chemotherapy for MM

- DONOR: HLA genotypically identical sibling

- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for
both peripheral blood stem cell (PBSC) allograft and subsequent DLI

- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral, subclavian)

- DONOR: Age < 75, older donors may be considered after consultation by Psychological
Consultation Center (PCC)

Exclusion Criteria:

- Karnofsky score less than 60, unless due solely to myeloma

- Left ventricular ejection fraction less than 40%

- Bilirubin greater than 2 X the upper limit of normal

- Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic
transaminase (SGOT) > 2 X the upper limit of normal

- Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving
continuous supplemental oxygen

- Patients with poorly controlled hypertension

- Pregnancy

- Seropositive for the human immunodeficiency virus

- Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment

- Creatinine clearance < 40 cc/min at the time of initial autografting evaluation

- Prior autograft (can be treated on alternative protocol)

- DONOR: Identical twin

- DONOR: Age less than 12 years

- DONOR: Pregnancy

- DONOR: Infection with human immunodeficiency virus (HIV)

- DONOR: Inability to achieve adequate venous access

- DONOR: Known allergy to G-CSF

- DONOR: Current serious systemic illness

- DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for
stem cell donation as described in the standard practice guidelines of the

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

The current study will be regarded as potentially efficacious if the observed 3-year PFS rate among all patients treated exceeds 30%. The Kaplan-Meier (KM) estimate of PFS will be used.

Outcome Time Frame:

From the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, up to 3 years

Safety Issue:


Principal Investigator

David Maloney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

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



Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
University of ColoradoDenver, Colorado  80217
City of HopeDuarte, California  91010