Completed

Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor

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What is being tested

therapeutic allogeneic lymphocytes

Biological
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1998
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: July 22, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy . Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients. OUTLINE: Patients receive initial cell dose of donor lymphocytes (CD3+ cells) IV over 15-30 minutes. Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3+ cells at a higher cell dose. Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3+ cells 8-12 weeks apart in the absence of unacceptable toxicity. Patients are evaluated at 4 and 8 weeks after each infusion. Patients with disease progression at 8 weeks are retreated at that time. Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated. Patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 2 years.

NCT00003153
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersMultiple MyelomaNeoplasms, Plasma Cell

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent multiple myeloma at least 6 months following allogeneic bone marrow transplantation (BMT) from an HLA identical sibling Must meet one of following criteria to be considered persistent, recurrent, or progressive disease: Residual detectable disease 6-12 months after BMT, as determined by the M protein level or bone marrow involvement, without further evidence of clinical or laboratory improvement on 2 consecutive measurements 4 weeks apart Complete response not achieved 12 or more months after BMT and there is no evidence of progressive improvement At least 25% increase of serum paraprotein (greater than 1.0 g/dL) as measured on two occasions or a 50% increase in urinary light chain excretion (greater than 150 mg/day) as measured on 2 occasions A 10% increase in plasma cells in the bone marrow Disease in complete response but with recurrence of M protein and 10% point increase in myeloma cells in the marrow allowed No lytic lesions alone or new soft tissue plasmacytoma as sole evidence of progression PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 times upper limit of normal Renal: Not specified Other: No active infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Must have received prior allogeneic bone marrow transplantation from an HLA A;B;DR genotypically matched sibling donor No concurrent interferon therapy for relapsed disease Chemotherapy: At least 4 weeks since cyclosporine, methotrexate, azathioprine, or other graft versus host disease (GVHD) prophylaxis/treatment without evidence of flare of GVHD At least 4 weeks since prior chemotherapy for relapsed disease Endocrine therapy: Must be receiving a dose no greater than 0.25 mg/kg prednisone for at least 4 weeks prior to registration without flare of GVHD No prior prednisone dose greater than 0.25 mg/kg in the past 4 weeks Must receive concurrent prednisone of a dose no greater than 0.25 mg/kg Concurrent corticosteroids allowed Radiotherapy: Concurrent palliative radiotherapy allowed if evidence of other evaluable disease other than irradiated bony sites Surgery: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Beth Israel Deaconess Medical Center

Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps

Medical College of Wisconsin Cancer Center

Milwaukee, United States
Completed2 Study Centers