NCT00635024 · REGISTRY CONDITION SEARCH

Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed 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: PHASE2
Status at capture: TERMINATED
Registry last update: 2017-02-10

RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.

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

Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Number of Participants With Severe Non-hematological Adverse Events

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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: DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma \- Relapsed disease * Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously * Measurable disease, defined by ≥ 1 of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * More than 200 mg of monoclonal protein in the urine on 24 hour electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Absolute neutrophil count ≥ 1,000/μL * Platelet count ≥ 75,000/μL * Hemoglobin ≥ 8.0 g/dL * CD4 \> 100/μL * Creatinine ≤ 3 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active malignancy with the exception of nonmelanoma skin cancer or in situ cervical or breast cancer * No uncontrolled infection * No other co-morbidity that would interfere with patient's ability to participate in trial PRIOR CONCURRENT THERAPY: * No limit to prior therapy * At least 4 weeks since prior melphalan or other myelosuppressive agents * At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids) * No concurrent high-dose corticosteroids * Concurrent chronic steroids (maximum dose 20 mg/day prednisone equivalent) allowed if they are being given for disorders other than amyloid (e.g., adrenal insufficiency or rheumatoid arthritis) * Concurrent continuation of low level/stable steroid doses for replacement or inhalation therapy allowed * Concurrent bisphosphonates allowed * No concurrent immunosuppressive medications such as cyclosporine * No other concurrent investigational treatment * No concurrent cytotoxic chemotherapy or external-beam radiotherapy\> * No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy * No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)
intervention Names
Biological: anti-thymocyte globulin
Drug: melphalan
label
Anti-thymocyte Globulin/Melphalan
type
EXPERIMENTAL

interventions

arm Group Labels
Anti-thymocyte Globulin/Melphalan
description
2.5 mg/kg
name
anti-thymocyte globulin
type
BIOLOGICAL
arm Group Labels
Anti-thymocyte Globulin/Melphalan
description
16 mg/m\^2
name
melphalan
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
measure
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
time Frame
4 months

secondary Outcomes

description
OS was defined as the time from registration to death of any cause.
measure
Overall Survival (OS)
time Frame
up to 2 years
description
PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * Bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas
measure
Progression-free Survival (PFS)
time Frame
up to 2 years
description
DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.
measure
Duration of Response (DOR)
time Frame
up to 2 years
description
Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)
measure
Number of Participants With Severe Non-hematological Adverse Events
time Frame
every month during treatment, up to 12 months

Full study description

brief Summary: RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.
detailed Description: OBJECTIVES: Primary \* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma. Secondary * To assess the toxicity and tolerability of this combination in these patients. * To assess time to disease progression in patients treated with these drugs. * To assess survival of patients treated with these drugs. OUTLINE: Patients receive anti-thymocyte globulin IV over 6 hours and melphalan IV on day 1. Treatment repeats every 28 days for 6 courses. Patients then receive melphalan alone as above for another 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice