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Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

anti-thymocyte globulin

melphalan

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-thymocyte Globulin/Melphalan

Arm Description

Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Overall Survival (OS)

OS was defined as the time from registration to death of any cause.

Progression-free Survival (PFS)

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

Duration of Response (DOR)

DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.

Number of Participants With Severe Non-hematological Adverse Events

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)

Full Information

NCT ID

NCT00635024

First Posted

March 12, 2008

Last Updated

December 20, 2016

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00635024

Brief Title

Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

Official Title

A Phase II Trial of Thymoglobulin and Melphalan in Patients With Relapsed Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Terminated

Why Stopped

Due to competing trials, this study is permanenlty closed to patient acrrual.

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anti-thymocyte Globulin/Melphalan

Arm Type

Experimental

Arm Description

Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)

Intervention Type

Biological

Intervention Name(s)

anti-thymocyte globulin

Intervention Description

2.5 mg/kg

Intervention Type

Drug

Intervention Name(s)

melphalan

Intervention Description

16 mg/m^2

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS was defined as the time from registration to death of any cause.

Time Frame

up to 2 years

Title

Progression-free Survival (PFS)

Description

Time Frame

up to 2 years

Title

Duration of Response (DOR)

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.

Time Frame

up to 2 years

Title

Number of Participants With Severe Non-hematological Adverse Events

Description

Time Frame

every month during treatment, up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaji K. Kumar, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

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Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

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