Clinical trial · Interventional

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)

NCT00064337CI-TRIAL-00034261completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Plasma Cell Myeloma	Multiple Myeloma	CURATED_BROADER	0.80

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
dexamethasone	Drug	Dexamethasone	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
melphalan	Drug	Melphalan	ALIAS
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
thalidomide	Drug	Thalidomide	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment
description
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.
interventionNames
1. Biological: filgrastim
2. Drug: cyclophosphamide
3. Drug: dexamethasone
4. Drug: melphalan
5. Drug: thalidomide
6. Procedure: peripheral blood stem cell transplantation

Primary outcomes (1)

measure
Overall Survival
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* At least 1 of the following diagnoses:

  * Multiple myeloma

    * Stage II or III disease
    * At least 1 of the following must be present:

      * Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL
      * Urinary M-protein (Bence-Jones) at least 200 mg/24 hours
    * No IgM peaks except in patients who have physiologic criteria to support a diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast nephropathy, absence of adenopathy \[unless pathology-proven to be plasma cell infiltration\])
    * No monoclonal gammopathy of undetermined significance
    * No indolent or smoldering myeloma
    * No disease progression on prior thalidomide or dexamethasone
  * Histologically confirmed primary systemic amyloidosis

    * No senile, secondary, localized, dialysis-related, or familial amyloidosis
    * No severe cardiac involvement

      * No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement
  * Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:

    * Deposition of granular material containing free light chains/immunoglobulins that did not bind Congo red
    * Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on bone marrow biopsy by immunohistochemistry and/or elevated serum-free light chain concentration
* Must have been diagnosed within the past year
* Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered

PATIENT CHARACTERISTICS:

Age

* 18 and over (patients with amyloidosis only OR patients with amyloidosis and multiple myeloma OR patients with multiple myeloma only with poor renal function) OR
* 70 and over (patients with multiple myeloma only with or without poor renal function)

Performance status

* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN

Renal

* No hemodialysis within 2 hours of melphalan or stem cell infusion

Cardiovascular

* See Disease Characteristics
* Hemodynamically stable (i.e., systolic blood pressure \> 90 mm Hg in a lying position within the past 42 days)
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No arrhythmia refractory to medical therapy
* LVEF greater than 45% by echocardiogram or MUGA

Pulmonary

* See Disease Characteristics
* No history of chronic obstructive or chronic restrictive pulmonary disease
* Pulmonary function studies (e.g., FEV\_1 and FVC) at least 50% of predicted
* DLCO at least 50% of predicted
* Normal high resolution CT scan of the chest and acceptable arterial blood gases (i.e., PO\_2 greater than 70) required for patients unable to complete pulmonary function tests due to bone pain or fracture

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

  * Multiple myeloma patients receiving thalidomide must use 2 methods of effective contraception for at least 4 weeks before, during, and for at least 4 weeks after discontinuation of thalidomide
* HIV negative
* No other concurrent significant medical condition
* No concurrent uncontrolled life-threatening infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* See Disease Characteristics
* Prior cumulative melphalan dose no more than 200 mg
* No other concurrent chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent hormonal therapy

Radiotherapy

* No concurrent radiotherapy

Surgery

* Not specified

Other

* Recovered from prior therapy
* Prior or concurrent bisphosphonates allowed

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jan 1, 2004
Primary completion: May 1, 2012
Completion: Nov 1, 2015
First posted: Jul 9, 2003
Last update posted: Aug 9, 2018
Results first posted: Nov 6, 2017
Enrollment: 104 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: primary systemic amyloidosis, stage II multiple myeloma, stage III multiple myeloma

Data updated 22 days agoSource updated Aug 9, 2018source: clinicaltrials

Locations

Locations by country (35)

Country	Sites	Recruiting
United States	35	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.