Phase 2
N=16
Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
Refractory Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00054353 ↗Enrolled (actual)
16
Serious AEs
31.3%
Results posted
Oct 2017
Primary outcome: Primary: PFS — 4; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fludarabine phosphate (Drug); melphalan (Drug); total-body irradiation (Radiation); mycophenolate mofetil (Drug); cyclosporine (Drug); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS |
4; 1 | — |
| PRIMARY Non-relapse Mortality |
1; 1 | — |
| PRIMARY Incidence of Acute GVHD (Grades III-IV) |
2; 0 | — |
| PRIMARY Incidence of Chronic (Extensive) GVHD |
4; 1 | — |
| SECONDARY OS |
8; 3; 5; 2; 4; 0 | — |
| SECONDARY Engraftment |
12; 4 | — |
| SECONDARY Relapse Rate |
1; 1 | — |
| SECONDARY Response Rate |
2; 1 | — |
Summary
This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.
Eligibility Criteria
Inclusion Criteria
- Meet Salmon and Durie criteria for initial diagnosis of MM; transplant will be offered to patients with previously treated MM who meet one of the following criteria:
- Patient received at least one prior autologous or syngeneic hematopoietic SCT (HSCT) and now has progressive disease (PD) (greater than 25% increase in serum or urine paraprotein levels compared to best response status after autograft or appearance of new lytic bone lesions or plasmocytomas)
- Patient is not able to collect autologous PBSC due to poor marrow reserve (insufficient HSC-mobilization: 50 years or there is a history of anthracycline exposure or history of cardiac disease
- Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL,or symptomatic biliary disease
- Diffusion capacity of carbon monoxide (DLCO) 20% risk of disease recurrence
- Pregnancy or breastfeeding
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Not fully recovered from previous high-dose therapy:
- Persistent mucositis and gastrointestinal symptoms requiring hyperalimentation and/or intravenous hydration
- On steroids for autologous/syngeneic GVHD
- On IV antibiotics for documented infections
- Cytomegalovirus (CMV)-antigenemia positive
- On ganciclovir or foscarnet for previous CMV reactivation/infection; off of this therapy for less than two weeks despite documented CMV-antigenemia- negativity (identification [ID] should be consulted if there is persistent CMV antigenemia post autograft)
- Ongoing radiotherapy
- Patients who meet any of these criteria may be discussed with the principal investigator for recommendations as to the timing of the allograft
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- DONOR: Identical twin
- DONOR: Donors unwilling to donate PBSC
- DONOR: Pregnancy
- DONOR: Infection with 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
- DONOR: Age < 12 years
- DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Data sourced from ClinicalTrials.gov (NCT00054353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.