H. Lee Moffitt Cancer Center & Research Institute

Clinical Research Protocols

CLINICAL RESEARCH PROTOCOLS FOR MULTIPLE MYELOMA


This list of clinical research protocols relating to
multiple myeloma is compiled for your convenience.

NCI High Priority Clinical Trial

SWOG-9321, INT-0141, CLB-9312 Phase III Randomized Study of L-PAM/TBI With PBSC Rescue vs VBMCP (VCR/BCNU/L-PAM/ CTX/PRED) Following Standard Induction for Previously Untreated Symptomatic Multiple Myeloma, With Further Randomization for Major Responders to IFN-A vs Observation (summary last modified: 12/97).

Chairperson: Bart Barlogie. Lead organization: Southwest Oncology Group. Age range: not over 70.

Phase III

CAN-NCIC-MY7, NCI-V95-0713 Phase III Randomized Study of L-PAM Plus DM vs PRED as Induction Therapy for Symptomatic Myeloma and of DM vs No Additional Treatment as Maintenance Therapy for Stabilized Disease (summary last modified: 10/96).

Chairperson: Chaim Shustik. Lead organization: NCIC-Clinical Trials Group. Age range: 18 and over.

MRC-LEUK-MYEL-VII, EU-94030 Phase III Randomized Study of Standard Therapy With ABCM (DOX/BCNU/CTX/L-PAM) vs Intensive Therapy With C-VAMP (CTX/ VCR/DOX/MePRDL) Followed by High-Dose L-PAM (With or Without TBI) With Hematopoietic Rescue, Both With IFN-A Maintenance, for Previously Untreated Myeloma (summary last modified: 02/95).

Chairperson: J. A. Child. Lead organization: Medical Research Council’s Working Party on Leukemia in Adults and Children. Age range: under 65.

MRC-LEUK-MYEL-VIII, EU-94031 Phase III Randomized Study of ABCM (DOX/BCNU/CTX/L-PAM) vs ABCM Followed by Oral CTX/PRED for Induction of First Plateau Phase in Elderly Patients With Multiple Myeloma (summary last modified: 09/95).

Chairperson: Ian C.M. MacLennan. Lead organization: Medical Research Council’s Working Party on Leukemia in Adults and Children. Age range: under 75.

E-5A93 Phase III Randomized Study of VBMCP (VCR/BCNU/L-PAM/CTX/PRED) Alone vs VBMCP Alternating First With High-Dose CTX, Then With IFN-A in Patients With Previously Untreated Multiple Myeloma (summary last modified: 18 and over).

Chairperson: Robert A. Kyle. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

E-1A95, CAN-NCIC-J1A95, CAN- NCIC-MY8, SWOG-S1A95 Phase III Randomized Study of Vincristine/ Doxorubicin/Dexamethasone (VAD) With vs Without PSC 833 in Relapsed/Refractory Multiple Myeloma (summary last modified: 03/98).

Chairperson: William R. Friedenberg. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

Phase II

MAYO-928003, NCI-V95-0613 Phase II Study of High-Dose L-PAM Plus TBI With PBSC Rescue for Multiple Myeloma in First Relapse (summary last modified: 06/95).

Chairperson: Morie Abraham Gertz. Lead organization: Mayo Clinical Cancer Center. Age range: 18-65.

FHCRC-1204.00, NCI-H97-0007 Phase II Study of Busulfan, Melphalan, and Thiotepa Followed by Autologous or Syngeneic Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma (summary last modified: 02/98).

Chairperson: William I. Bensinger. Lead organization: Fred Hutchinson Cancer Research Center. Age range: 70 and under.

WSU-C-1257, NCI-T95-0062D, WSU-D-1257 Phase II Study of Bryostatin 1 in Relapsed Multiple Myeloma (summary last modified: 06/97)

Chairperson: Mary L. Varterasian. Lead organization: Barbara Ann Karmanos Cancer Institute. Age range: 18 and over.

MAYO-968001, NCI-V96-1079 Phase II Study of High-Dose Dexamethasone for Primary Systemic Amyloidosis (summary last modified: 12/96).

Chairperson: Morie Abraham Gertz. Lead organization: Mayo Clinical Cancer Center. Age range: 18 and over.

UARK-94016, NCI-T94-0176O Phase II Pilot Study of Suramin for Refractory or Relapsed Multiple Myeloma and Castleman’s Disease (summary last modified: 01/97).

Chairperson: Madhav Dhodapkar. Lead organization: University of Arkansas for Medical Sciences - Little Rock. Age range: over 18.

SWOG-S9628, SWOG-9628 Phase II Study of Dexamethasone/Interferon alfa for Primary Systemic Amyloidosis (summary last modified: 03/98).

Chairperson: Madhav Dhodapkar. Lead organization: Southwest Oncology Group. Age range: adult.

MAYO-958002, NCI-V96-0837 Phase II Study of TBI Plus High-Dose L-PAM With PBSC Rescue for Primary Systemic Amyloidosis (summary last modified: 06/96).

Chairperson: Morie Abraham Gertz. Lead organization: Mayo Clinical Cancer Center. Age range: 18-70.

MCW-96110, NCI-V97-1368, MCW- HRRC-29196 Phase II Study of Myeloablative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma or Other B-Cell Malignancies (summary last modified: 02/98).

Chairperson: David H. Vesole. Lead organization: Medical College of Wisconsin. Age range: 18 and over.

WSU-D-701-87, NCI-V94-0364 Phase II Study of Bone Marrow Transplantation for Refractory or High-Risk Non-Hodgkin’s Lymphoma, Hodgkin’s Disease, and Multiple Myeloma (summary last modified: 10/97).

Chairperson: Chatchada Karanes. Lead organization: Barbara Ann Karmanos Cancer Institute. Age range: not over 60.

FHCRC-1272.00, NCI-H98-0009 Phase II Study of Total Marrow Irradiation, Busulfan, and Interfer on Alfa Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation in Patients With Advanced Multiple Myeloma (summary last modified: 03/98).

Chairperson: William I. Bensinger. Lead organization: Fred Hutchinson Cancer Research Center. Age range: 18 to 65.

PCI-9317, NCI-V93-0287 Phase II Study of High-Dose Chemotherapy and Autologous Stem Cell Support Followed by Low-Dose IL-2 in Patients With Relapsed or Resistant Multiple Myeloma (summary last modified: 12/93.

Chairperson: Witold B. Rybka. Lead organization: University of Pittsburgh Cancer Institute. Age range: over 18 to under 65.

CHNMC-94087-94-11-1, NCI-V94- 0590 Phase II Pilot Study of Sequential High-Dose L-PAM and BU/CTX Followed by PBSC Rescue for Multiple Myeloma (summary last modified: 03/95.

Chairperson: George Somlo. Lead organization: Beckman Research Institute of the City of Hope. Age range: 65 and under.

NCI-97-C-0033, NCI-T94-0094N, CRB-9409 Phase II Evaluation of Cellular and Humoral Immunity Against a Tumor-Derived Immunoglobulin Idiotype in Multiple Myeloma Patients Undergoing Autologous PBMC Transplantation after Idiotype Vaccination (summary last modified: 05/97).

Chairperson: Larry W. Kwak. Lead organization: Division of Clinical Sciences. Age range: any age.

TUHSC-2797, NCI-V96-0951 Phase II Study of High-Dose Melphalan Followed by Autologous Peripheral Blood Stem Cell Transplantation in Primary Amyloidosis or Amyloidosis Secondary to Multiple Myeloma (summary last modified 01/98).

Chairperson: Kenneth F. Mangan. Lead organization: Temple University Cancer Center. Age range: 16 to 65.

SWOG-S9612, SWOG-9612 Phase II Study of Oral VP-16 and Intravenous BCNU in Refractory Multiple Myeloma (summary last modified: 05/96).

Chairperson: Charles A. Coltman, Jr. Lead organization: Southwest Oncology Group. Age range: no age specified.

E-2A97 Phase II Study of Docetaxel in Patients With Relapsed or Refractory Multiple Myeloma (summary last modified: 04/98).

Chairperson: William R. Friedenberg. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

NCI-97-C-0030, NCI-T94-0085N, CRB-9407 Phase II Study of Active Immunization of Related Bone Marrow Transplant Donors Against Purified Myeloma Protein from the Recipient Undergoing Allogeneic Bone Marrow Transplantation (summary last modified: 02/98).

Chairperson: Larry W. Kwak. Lead organization: Division of Clinical Sciences. Age range: under 60.

E-1A97 Phase II Study of Salvage Cellular Immunotherapy With Donor Lymphocyte Infusions in Patients With Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation from an HLA-Matched Sibling Donor (summary last modified: 04/98).

Chairperson: Neal Flomenberg. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

E-1A96 Phase II Study of Interleukin-12 (IL-12) in Patients With Plateau Phase Multiple Myeloma (summary last modified: 04/98).

Chairperson: Martha Q. Lacy. Lead organization: Eastern Cooperative Oncology Group. Age range: 18 and over.

Phase I/Pilot Studies

FHCRC-1104.00, NCI-H96-0924 Phase I Study of Posttransplant Immunization With Autologous Myeloma Idiotype (Id) Conjugated to Keyhole Limpet Hemocyanin (KLH) and Administered With GM-CSF Following Autologous or Allogeneic Marrow or Stem Cell Transplantation in Myeloma Patients (summary last modified: 02/98).

Chairperson: David G. Maloney. Lead organization: Fred Hutchinson Cancer Research Center. Age range: 18 to 65.

MDA-DM-91104, NCI-G96-0992 Phase I Trial of 166 Holmium- DOTMP With Autologous Bone Marrow Transplantation for Advanced Multiple Myeloma (summary last modified: 06/97).

Chairperson: Richard E. Champlin. Lead organization: University of Texas - M.D. Anderson Cancer Center. Age range: less than 60.

UTENNM-BCG-5889, NCI-V97-1263 Pilot Study of Interferon Alfa-2b (Intron A) Maintenance in Patients With Advanced Multiple Myeloma Who Have Used High Dose Melphalan (L-PAM) as Myeloablative Chemotherapy (summary last modified: 02/98).

Chairperson: C. Michael Jones. Lead organization: University of Tennessee, Memphis. Age range: 19 to 64.

MDA-DM-94132, NCI-G96-1006 Phase I/II Randomized Study of Cyclosporine Induced Autologous Graft Versus Host Disease (GVHD) Following Peripheral Blood Stem Cell Transplantation in Multiple Myeloma (summary last modified: 06/97).

Chairperson: Sergio Giralt. Lead organization: University of Texas - M.D. Anderson Cancer Center. Age range: 15 to 60.

STLMC-BRM-9501, NCI-V95-0735 Phase I Study of Cytotoxic T-Cell Infusion With PBSC Transplantation for Acute Leukemia, Hodgkin’s Disease, non-Hodgkin’s Lymphoma, and Multiple Myeloma (summary last modified: 01/98).

Chairperson: Lawrence George Lum. Lead organization: St. Luke’s Medical Center. Age range: 13 and over.

FHCRC-976.02, NCI-H95-0703, FHCRC-976.01 Phase I Pilot Study of Interleukin-2-Activated Peripheral Blood Stem Cell Rescue Following Myeloablative Chemotherapy and of Post-Transplant Interleukin-2 for Stage IV Breast Cancer and Advanced Lymphoma, Multiple Myeloma, and Ovarian Cancer (summary last modified: 02/98).

Chairperson: Leona Holmberg. Lead organization: Fred Hutchinson Cancer Research Center. Age range: 18 to 55.

Support

URCC-U10994, NCI-P96-0073, NCI-C95-0001, URCC-10994P(M) Randomized Study of Trimethoprim-Sulfamethoxazole vs Cipro-floxacin or Ofloxacin vs No Prophylaxis for the Prevention of Early Infection in Multiple Myeloma Patients (summary last modified: 12/97).

Chairperson: John M. Bennett. Lead organization: University of Rochester Cancer Center. Age range: any age.

Legend for Abbreviations:

CAN-NCIC = National Cancer Institute of Canada

CHNMC = City of Hope National Medical Center

E = Eastern Cooperative Oncology Group

EU = NCI-Liaison Office- Approved Eutopean Voluntary Protocol

FHCRC = Fred Hutchinson Cancer Research Center

MAYO = Mayo Clinic

MCW = Medical College of Wisconsin

MDA = M. D. Anderson Cancer Center

MRC = Medical Research Council

PCI = Pittsburgh Cancer Institute

STLMC = St. Luke’s Medical Center

SWOG = Southwest Oncology Group

TUHSC = Temple University Health Sciences Center

UARK = University of Arkansas

URCC = University of Rochester Cancer Center

UTENNM = University of Tennessee College of Medicine

WSU = Wayne State University


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