Autologous Transplant for Multiple Myeloma

NCT00177047 | Completed Phase 2 Results DMC

• 3 other identifiers: 2004LS001MT2003-130312M54569
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Conditions

Multiple Myeloma

Keywords

stem cell transplantation; chemotherapy; multiple myeloma; autologous

Outcome Measures

Primary Outcomes (3)

• Number of Participants Achieving a Complete Response

  Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

  100 Days post transplant

• Number of Participants Achieving a Complete Response

  Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

  6 months post transplant

• Number of Participants Achieving a Complete Response

  Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

  12 months post transplant

Secondary Outcomes (16)

• Number of Patients With Extended Disease-free Survival

  36 Months

• Number of Participants With Overall Survival

  1 year

• Number of Participants With Overall Survival

  2 years

• Number of Participants With Overall Survival

  3 years

• Count of Participants Experiencing Transplant Related Mortality

  1 year

Study Arms (1)

Chemotherapy and Transplant Treatment

EXPERIMENTAL

Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.

Procedure: Stem Cell Transplant; Drug: Cyclophosphamide + Mesna; Drug: Melphalan; Biological: Granulocyte-colony stimulating factor

Interventions

Stem Cell Transplant PROCEDURE

As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.

Also known as: Bone Marrow Transplant

Chemotherapy and Transplant Treatment

Cyclophosphamide + Mesna DRUG

Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.

Also known as: Cytoxan

Chemotherapy and Transplant Treatment

Melphalan DRUG

Administered intravenously 200 mg/m\^2

Also known as: Alkeran

Chemotherapy and Transplant Treatment

Granulocyte-colony stimulating factor BIOLOGICAL

Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Also known as: G-CSF

Chemotherapy and Transplant Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
• After initial therapy in either first complete or partial remission or no objective response
• After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
• Is not eligible or has refused any protocols of higher priority
• years of age
• Adequate organ function defined as:
• Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
• Cardiac: no active ischemia, left ventricular ejection fraction \> 45% by MUGA scan
• Hepatic: bilirubin \< 2.0 mg/dl, ALT \< 3x the upper limit of normal
• Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) \>50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) \> 50% predicted
• Performance status: Karnofsky performance of \> 80%.
• Free of active uncontrolled infection at the time of study entry.
• At time of study enrollment \> 4 weeks from prior myelosuppressive chemotherapy; and \> 6 weeks from prior nitrosoureas.
• Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

You may not qualify if:

• Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
• Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Stem Cell Transplantation; Bone Marrow Transplantation; Cyclophosphamide; Mesna; Melphalan; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Tissue Transplantation; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors

Results Point of Contact

• Title: Dr.Claudio G. Brunstein MD, PhD
• Organization: Masonic Cancer Center, University of Minnesota

bruns072@umn.edu

612-625-3918

Study Officials

• Claudio Brunstein, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: April 20, 2004
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Locations

US (1)