Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702247

Enrollment

Unknown

Registered

2008-06-20

Start date

1999-07-31

Completion date

Unknown

Last updated

2008-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response

Brief summary

To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

Interventions

PROCEDUREHematopoietic Stem Cell Transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Durie-Salmon stage IIA-IIIB multiple myeloma * Age \> 18 and ≤ 65 years * Previously untreated myeloma * Presence of a sibling (potential donor) * Bilirubins \< twice normal;ALAT and ASAT \< four times normal * Left ventricular ejection fraction \> 40% * Creatinine clearances \> 40 mL/min * Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) \> 40% and/or need for continuous oxygen supplementation * Karnofsky performance status \> 60% * Patients must give written informed consent

Exclusion criteria

* Age \> 65 years * Previously treated myeloma * Absence of a sibling (genetic randomisation cannot be applied) * Karnofsky performance status score \< 60% * HIV-infection * Pregnancy * Refusal to use contraceptive techniques during and for 12 months following treatment * Patients unable to give written informed consent * PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Design outcomes

Primary

Measure	Time frame
overall survival	yearly

Secondary

Measure	Time frame
event free survival	yearly

Countries

Italy

Contacts

Primary ContactBenedetto Bruno, MD, PhD

benedetto.bruno@unito.it+39-011-6334419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026