NCT02043860 · REGISTRY CONDITION SEARCH

Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: TERMINATED
Registry last update: 2019-10-14

In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Patients meeting criteria for symptomatic myeloma 2. Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy 3. Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months 4. Patient age 18-75 years at time of enrollment 5. Karnofsky performance status of ≥70 6. Cardiac function: LVEF \>40% 7. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal 8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated 9. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin) Exclusion Criteria: 1. Patients with diagnosis of plasma cell leukemia 2. Patients with myeloma who have had any disease progression prior to enrollment 3. Patients with truly non secretory myeloma (patients with light chain disease are eligible) 4. Pregnant or breast-feeding 5. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis. 6. Patients who have undergone prior allograft or autologous transplant 7. Prior solid organ transplant 8. Patients receiving prior radiation to more than 20% of bone marrow containing areas
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
intervention Names
Radiation: Total Marrow Irradiation
Procedure: Autologous Transplant
Drug: Melphalan
Drug: Filgrastim (G-CSF)
label
Total Marrow Irradiation
type
EXPERIMENTAL

interventions

arm Group Labels
Total Marrow Irradiation
description
Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.
name
Total Marrow Irradiation
type
RADIATION
arm Group Labels
Total Marrow Irradiation
description
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.
name
Autologous Transplant
type
PROCEDURE
arm Group Labels
Total Marrow Irradiation
description
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant.
name
Melphalan
other Names
Alkeran ®
type
DRUG
arm Group Labels
Total Marrow Irradiation
description
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days.
name
Filgrastim (G-CSF)
other Names
Neupogen®
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
measure
Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze
time Frame
Up to 1 year post-transplant.

Full study description

brief Summary: In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.
detailed Description: To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice