MDACC Study Summary 2003-0630 (Archived)

Study Summary
No. 2003-0630:.......Blood And Marrow Transplantation; Myeloma......Muzaffar H. Qazilbash......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2003-0630

Study Title:	A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologus Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma (BMT CTN Protocol 0102)

Physician

New Patient Referral



Name:	Muzaffar H. Qazilbash	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Myeloma	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	As per current BMT guidelines.

Treatment Agents:	Dexamethasone Melphalan Radiation Thalidomide	Home Care:	Patients will be receiving thalidomide and dexamethasone at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	30 days for each transplant.


Description/ Intervention:	The goal of this research study is to learn if a blood stem cell transplant will help to control your sibling's MM. This consent describes the collection of stem cells from your blood to transplant into your sibling. The donation process for stem cells is not experimental. The treatment of your sibling is the research part of this study.

Study Objectives / Outcomes

Primary Objective:

Post-tandem autologous transplant randomized trial of maintenance versus observation: The primary objective is to compare progression-free survival at three years between the two arms.

Tandem autologous transplants versus autologous transplant followed by HLA-matched sibling non-myeloablative allogeneic transplant: The primary objective is to compare progression-free survival at three years between the two arms.

Secondary Objective:

Post-tandem autologous transplant randomized trial of maintenance versus observation: Secondary objectives are to compare 'current' myeloma-stable survival, three-year overall survival, and incidence of progression.

Tandem autologous transplants versus autologous transplant followed by HLA-matched sibling non-myeloablative allogeneic transplant: Secondary objectives are to compare 'current' myeloma-stable survival, three year overall survival, and incidence of progression.

Tertiary Objective:

Post-tandem autologous transplant randomized trial of maintenance versus observation: Tertiary objectives include complete remission (CR) rate and CR+partial remission (PR) rate at 2 and 12 months after the second transplant, time to CR and CR+PR, time to off-study therapy, rate of discontinuation of maintenance therapy and duration of maintenance therapy, incidence of toxicities Grade 3 according to the CTCAE Version 3.0, incidence of infections and quality of life.

Tandem autologous transplants versus autologous transplant followed by HLA-matched sibling non-myeloablative allogeneic transplant: Tertiary objectives include CR and CR+PR rates at 2 and 12 months after the allograft, time to CR and CR+PR, time to second transplant, time to off-study therapy, and quality of life.

Other tertiary outcomes to be evaluated only in the allogeneic transplant arm will include incidence of both primary and secondary graft failure and incidence and severity of graft-versus-host-disease

Study Status Information



Study Activation / Registration Date:	12/17/2003

IRB Review and Approval Date:	11/05/2003

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	500

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Meet the Durie and Salmon criteria for initial diagnosis of MM .

2) Stage II or III Multiple Myeloma

3) Symptomatic Multiple Myeloma requiring treatment

4) 70 years or younger

5) Received at least three cycles of initial systemic therapy and within 2-10 months of tx

6) Chemotherapy-base mobilization regimens must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy

7) Patients with adequate organ function

8) Patients with autologous graft - cryopreserved PBSC graft containing > 4.0 x 106 CD34+ cells/kg

Exclusion Criteria:

1) Patients that have never advanced beyond Stage I MM since diagnosis (Appendix A)

2) Patients with non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immjnofixation techniques].

3) Patients with plasma cell leukemia.

4) Karnofsky performance score less than 70% unless approved by the Medical Monitor or one of the Protocol Chairs.

5) Patients with uncontrolled hypertension

6) Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).

7) Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Medical Monitor or one of the Protocol Chairs. Cancer treated with curative intent > 5 years previously will be allowed.

8) Female patients who are pregnant (positive B-HCG) or breastfeeding.

9) Patients seropositive for the human immunodeficiency virus (HIV).

10) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.

11) Prior allograft or prior autograft.

12) Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.

13) Patients unable or unwilling to provide informed consent.

14) Prior organ transplant requiring immunosuppressive therapy.

Links

Registration Number: NCT00075829
Study Information on Clinical Trials Registry (clinicaltrials.gov)