Myelom-Gruppe Rhein-Main

Last modified: 12 January 2013

Planned/active studies in multiple myeloma

Following is a list of planned and ongoing clinical studies in the field of multiple myeloma. This list makes no claim to be exhaustive. There may be a lot more clinical studies in your country or region that are not yet included in this list.

If you are aware of any planned or active clinical studies that should be listed here, please complete the clinical studies submission form and send it to us. Myeloma Euronet will double-check this information before including the study in the list below.

To keep this list manageable, information about clinical studies is provided in English only. If you don’t understand English, please ask someone in your family circle or a friend to assist you.


 

 

Status
Study title
Phase
Condition/s Intervention/s Sponsor/s
further details

Recruiting participants

MM5 Trial: Randomised phase III trial for previously untreated multiple myeloma to evaluate two regimens of bortezomib based induction therapy and
lenalidomide consolidation followed by lenalidomide maintenance treatment

PHASE: III

Newly diagnosed multiple myeloma

  • 3 cycles induction treatment: PAd (bortezomib, adriamycin, dexamethasone) vs. VCD (bortezomib, cyclophosphamide, dexamethasone)
  • standard intensification chemotherapy (stem cell mobilisation, G-CSF and leukapheresis, high dose melphalane followed by autologous stem cell transplantation)
  • 2 cycles of lenalidomide consolidation
  • lenalidomide maintenance treatment for 2 years vs. lenalidomide maintenance treatment until complete response (CR)

Sponsors and collaborators:
University Hospital Heidelberg, Germany (Sponsor)
Hospitals of the German-Speaking Myeloma Multicenter Group

Information received:
August, 18 2010

Additional information ›

Recruiting participants

A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma

PHASE: III Study

Relapsed or relapsed-and-refractory Multiple Myeloma in patients that have received one to three prior lines of therapy, and who are not refractory to bortezomib (Velcade)

Panobinostat + Bortezomib + Dexamethasone

Sponsors and collaborators:
Novartis PHARMA A.G

Information received:
July, 12 2010

Additional information ›

Recruiting participants

An international, multicenter, randomized, double-blind study of Vorinostat or placebo in combination with Bortezomib in patients with Multiple Myeloma.

PHASE: III Study

>18 years aged patients who have relapsed multiple myeloma after at least 1 but not more than 3 prior treatment regimen, based upon the standard myeloma diagnostic criteria

2 arm study with combination of intravenous Bortezomib and oral Vorinostat vs. Bortezomib and Placebo.

Sponsors and collaborators:
Merck & Co., Inc., USA

Information received:
March, 19 2010

Additional information ›

Recruiting participants

A study to determine the efficacy and safety of lenalidomide plus low-dose dexamethasone when given until progressive disease or for 18 four-week cycles versus the combination of melphalan, prednisone, and thalidomide given for 12 six-week cycles.

PHASE: III

Patients with previously untreated multiple myeloma who are either 65 years of age or older or not candidates for stem cell transplantation

3 treatment arms:

  • lenalidomide plus low-dose dexamethasone until progressive disease (cycles à 4 weeks), or
  • lenalidomide plus low-dose dexamethasone for 18 cycles (à 4 weeks), or
  • melphalan plus prednisone plus thalidomide for 12 cycles (à 6 weeks).

Sponsors and collaborators:
Celgene Corporation

Information received:
March, 03 2010

Additional information ›

Recruiting participants

Vorinostat (MK-0683) or placebo in combination with bortezomib
in patients with multiple myeloma

PHASE: III

Patients with multiple myeloma after at least 1 prior treatment regimen

All study medications are recommended to be administered on an outpatient basis. All eligible patients will be treated with bortezomib administered by IV push on days 1, 4, 8 and 11 of each 21 day treatment cycle.

In addition, all eligible patients will be assigned to treatment with either oral vorinostat (400 mg) or matching placebo. Blinded study therapy will be administered once daily on days 1 through 14 of each 21 day treatment cycle. Treatment will be given until disease progression.

Sponsors and collaborators:
Merck & Co., Inc.

Information received:
March, 03 2010

Additional information ›

Active, not recruiting

GMMG-HD4/HOVON 65 MM:
A randomized phase III study on the effect of Bortezomib combined with Adriamycin, Dexamethasone (AD) for induction treatment, followed by High Dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma

PHASE: III

Newly diagnosed multiple myeloma

  • 3 cycles induction treatment:
  • VAD (vincristine, adriamycin, dexamethasone) vs. PAD (bortezomib, adriamycin, dexamethasone)
  • stem cell mobilisation: 1 cycle CAD (cyclophosphamide, adriamycin, dexamethasone) followed by G-CSF and leukapheresis
  • high dose melphalan followed by autologous stem cell transplantation: 1-2 cycles
  • 2 years maintenance treatment: thalidomide vs. bortezomib

Sponsors and collaborators:
University Hospital Heidelberg,
German-Speaking Myeloma Multicenter Group,
HOVON Study group (Netherlands)

Information received:
March, 15 2010

Additional information ›

Recruiting participants

Randomized, placebo-controlled, monocentric, double-blind study concerning the efficacy and safety of Aprepitant in combination with Kevatril and Dexamethasone vs. placebo in combination with Kevatril and Dexamethasone for the prevention of acute and delayed Nausea and Emesis after high-dose chemotherapy in patients with Multiple Myeloma and autologous peripheral blood stem cell transplantation.

PHASE: III B Study

Nausea and emesis after high-dose Melphalan and autologous blood stem cell transplantation

Placebo-controlled administration of Aprepitant vs. Placebo in this situation (see title of the study)

Sponsors and collaborators:
IIT-Study, supported by MSD Sharp & Dohme

Information received:
March, 19 2010

Additional information ›

Recruiting participants

An international, multicenter, open-label study of Vorinostat in combination with Bortezomib in Patients with relapsed and refractory Multiple Myeloma

PHASE: IIb

>18 years aged patients who have relapsed and refractory multiple myeloma after at least 2 prior treatment regimens as per the EBMT response criteria

Single arm trial with combination of intravenous Bortezomib and oral Vorinostat

Sponsors and collaborators:
Merck & Co., Inc., USA

Information received:
March, 19 2010

Additional information ›

Recruiting participants

A Phase IIa, Proof of Concept Study to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients with Multiple Myeloma

PHASE: IIa

  • Patients suffering of multiple myeloma in stages phase II-III according to criteria of Salmon and Durie
  • Male or female 18-70 years of age, inclusive
  • Patients who have undergone a 3 cycles of induction chemotherapy (PD or PAD or TD or TAD)

Stem cell mobilisation with the CXCR4 antagonist POL6326

Sponsors and collaborators:
Polyphor AG

Information received:
March, 15 2010

Additional information ›

Recruiting participants

Autologous – Allogeneic Tandem Stem Cell Transplantation and Maintenance
Therapy with Thalidomide/ DLI for patients with Multiple Myelopma (MM) and age

PHASE: Multicenter phase II trial

  • Multiple Myeloma stage II or III according to Salmon and Durie
  • Age < 60 years
  • Maximum of 8 chemotherapy cycles prior registration
  • Auto/Auto Stem Cell Transplantation ( no suitable stem-cell donor)
    > Followed by maintenance therapy with low-dose thalidomide
  • Auto/Allo Stem Cell Transplantation ( with a suitable stem-cell donor)
    > Followed by maintenance therapy with low-dose thalidomide and donor-lymphocyte infusions

Sponsors and collaborators:
University Medical Center Hamburg-Eppendorf (Sponsor)

Information received:
April, 15 2010

Additional information ›

Recruiting participants

Phase II Dose Optimization, Open-Label Clinical Trial of Zalypsis® (PM00104) in Relapsed/Refractory Multiple Myeloma Patients.

PHASE: II

Relapsed/Refractory Multiple Myeloma

Zalypsis (PM00104) monotherapy. A marine compound that induces DNA damage.

Sponsors and collaborators:
Pharmamar

Information received:
February, 26 2010

Additional information on clinicaltrials.gov › (There is no information about this trial in clinicaltrials.gov yet)

Recruiting participants

Lenalidomide and Dexamethasone for the treatment of patients with acute myeloma (light chain)-induced renal failure

PHASE: II

Multiple myeloma and acute light chain induced renal failure

9 cycles (à 28 days):
lenalidomide (orally on days 1-21) plus dexamethasone (for the first cycle 40mg orally on days 1-4, 9-12, 17-21; thereafter 40mg orally once weekly); lenalidomide dose is adapted to renal function (creatinine clearance).

Sponsors and collaborators:
This study sponsored by CEMSG (Central European Myeloma Study Group) is performed in 3 European countries (Austria, Czech Republic, Slovakia) with 11 participating study sites.

Information received:
March, 03 2010

Additional information ›

Recruiting participants

Dose-finding study of lenalidomide as maintenance therapy in multiple myeloma after allogeneic stem cell transplantation

PHASE: I/II

Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago).

Lenalidomid-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three-dose levels will be investigated.
Dose-level-1: 2,5 ng/d if 2,5 mg capsules are available, day 1-21, otherwise

  • 5 mg every other day, day 1-21
  • Dose-level 0: 5 mg/d, day 1-21
  • Dose-level 1: 10 mg/d, day 1-21
  • Dose-level 2: 15 mg/d, day 1-21

Sponsor:
University Medical Center Hamburg Eppendorf
Collaborators:
University Hospital Heidelberg

Information received:
July, 08 2010

Additional information: