THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

About this study

Official title: Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma

Conditions

Multiple Myeloma

Being tested

Thalidomide, Dexamethasone, Zoledronic acid, Cyclophosphamide, Melphalan

Keywords

autologous stem cell transplantation, thalidomide, induction therapy

Medical subject headings

Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ThalidomideDrug

  • INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-120 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)
  • AFTER PBSC COLLECTION: 200 mg/d from day after last PBSC collection until the day before first course of MEL-200
  • AFTER FIRST TRANSPLANTATION: 200 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200

• DexamethasoneDrug

  • INDUCTION THERAPY: 40 mg/d days 1-4, 9-12 and 17-20 (cycles 1 and 3, 30 days each); 40 mg/d days 1-4 (cycles 2 and 4, 30 days each)
  • AFTER PBSC COLLECTION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide)
  • AFTER FIRST TRANSPLANTATION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)

• Zoledronic acidDrug

  • INDUCTION THERAPY: 4 mg i.v. once a cycle for 4 cycles (30 days each)
  • AFTER PBSC COLLECTION: 4 mg i.v. once (the same day of resumption of Thalidomide)
  • AFTER FIRST TRANSPLANTATION: 4 mg i.v. once a cycle (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)

• CyclophosphamideDrug

  Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation

• MelphalanDrug

  Melphalan 200 mg/sqm on day -1 for first and second ASCT

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction

   Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).

   Measured: 120 days after the start day of tal-dex induction therapy

2. duration of response (partial response, PR, very good partial response, VGPR, complete response, CR)

   Duration of response is calculated from the first achievement of the response (at least PR, at least VGPR, at least CR) to relapse/progression

   Measured: Average time period between the day of first achievement of response and the day of first relapse or progression

3. time to progression (TTP)

   TTP is calculated from the start date of induction therapy to the date of relapse/progression

   Measured: Average time period between the start day of induction therapy and the day of relapse or progression

4. progression free survival (PFS)

   PFS is calculated from the start date of induction therapy to the date of relapse/progression or death for any cause, whichever occurs first

   Measured: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly

5. toxicity of thal-dex (induction and subsequent treatment phases)

   Adverse events are assessed monthly and graded according to the National Cancer Institute Common Toxicity Criteria, version 2. Safety is monitored until 30 days after the last dose of study drug.

   Measured: Within 30 days after the last dose of study drug

6. Response rate (at least PR, VGPR, nCR and CR) to first ASCT

   Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).

   Measured: 90 days after first ASCT

7. Response rate (at least PR, VGPR, nCR and CR) to second ASCT

   Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).

   Measured: 90 days after second ASCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Apr 2011 (estimated)
2. Study startMar 2002
3. Primary completionOct 2007
4. Study completionJan 2009

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Multiple MyelomaStudies of the same condition, open and under way.
• More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.