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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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



* To evaluate the hematological response rate of anti-thymocyte globulin given in
combination with melphalan in patients with relapsed multiple myeloma.


- 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

After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 2 years.

Inclusion Criteria


- 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)


- 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


- 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)

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Shaji K. Kumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Rochester, Minnesota  55905