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A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Lenalidomide

dexamethasone

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring CC-5013, Revlimid, Lenalidomide, Celgene, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must understand and voluntarily sign an informed consent form.
Must be ≥18 years of age at the time of signing the informed consent form.
Must be able to adhere to the study visit schedule and other protocol requirements.
Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).
Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
- Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
- Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells.
- Serum creatinine >2.5 mg/dL (221 µmol/L)
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
- Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥1 year.
Prior history of stroke and/or thromboembolic event
Known hypersensitivity to thalidomide or dexamethasone.
Prior history of uncontrollable side effects to dexamethasone therapy.
The development of a desquamating rash while taking thalidomide.
Neuropathy ≥ Grade 2.

Sites / Locations

Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte
Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn
Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH
Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH
Interne Klinik Dr. Argirov, Schön-Kliniken
Klinik für Innere Medizin III Klinikum Chemnitz gGmbH
Medizinische Klinik und Poliklinik, Uniklinikum Dresden
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Direktor der Klinik f. Hämatologie, Universitätsklinikum Essen
Universitätsklinikum EssenInnere Klinik und Poliklinik
Klinik für Innere Medizin, Klinikum Frankfurt (Oder) GmbH
Medizinische Klinik II (ZIM),Hämatologie / Onkologie Uniklinik Frankfurt
Abt. Innere Medizin I , Hämatologie / Onkologie, Universitätsklinikum Freiburg
Universitätsklinikum GöttingenHamatologie und Onkologie
Interdisziplinäre Klinik und Poliklinik für Stammzellentransplantation Universitätsklinik Hamburg - Eppendorf
II. Medizinische Abteilung, Asklepios Klinikum Altona
Abt. Hämatologie, Hämatologie und Onkologie, Medizinische Hochschule Hannover
Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg
Klinik für Innere Medizin II Hämatologie / Onkologie Universitätsklinikum Jena
EPS - Early Phase Solutions GmbH
Hämatologie / Onkologie / Infektionskrankheiten, Palliativmedizin Städtisches Klinikum Karlsruhe
2. Med. Klinik , Sektion f. Stammzell- + Immuntherapie Universitätsklinikum Schleswig-Holstein
Institut für Versorgungsforschung in der Onkologie Praxisklinik für Hämatologie und Onkologie
Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hämatologie u. Onkologie
Klinik f. Innere Medizin, Klinikum der Universität zu Köln
Medizinische Klinik und Poliklinik II Abt. Hämatologie / Onkologie, Universitätsklinikum Leipzig AÖR
III. Med. Klinik, Johannes Gutenberg Universität
Klinikum Mannheim der Universität Heidelberg
Hämatologisch-Onkologisches Institut für medizinische Service Leistungen
Medizinische Klinik III Klinikum der Universität München-Großhadern
Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster
Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis
Onkologie Praxis Oldenburg
Abt. Onkologie/ Hämatologie, Klinikum Oldenburg
Abteilung Hämatologie und Onkologie, Hämatologie und Onkologie, Medizinische Klinik, Klinikum Ernst v. Bergmann
Klinikum der Universität Regensburg
Abteilung Hämatologie und Onkologie, Medizinische Fakultät der Universität Rostock
Caritasklinik St. Theresia
ms² Medizinische Statistik Saarbrücken
Med. Klinik III , St. Marienkrankenhaus Siegen
Zentrum für Innere Medizin II Robert- Bosch-Krankenhaus GmBH
Krankenanstalt Mutterhaus der Borromäerinnen
Abt. II Hämatologie, Onkologie und Immunologie Medizinische Klinik Abt.II
Medizinische Universitätsklinik
Praxis Dres. Maintz & GroschekHämatologie / Onkologie
Med. Klinik 1, Helios Klinikum Wuppertal
Med. Klinik u. Poliklinik IIKlinikum der Universität Würzburg
Hämatologisch-onkologische Praxis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lenalidomide plus dexamethasone

Arm Description

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.

Outcomes

Primary Outcome Measures

Kaplan Meier Estimate for Time to Disease Progression

Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease. Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Secondary Outcome Measures

Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria

Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD). CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.

Participants With Treatment-emergent Adverse Experiences (TEAEs)

Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria

Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.

Full Information

NCT ID

NCT00478777

First Posted

May 23, 2007

Last Updated

September 26, 2011

Sponsor

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00478777

Brief Title

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Official Title

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone. This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany. Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study. Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles. Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany. Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed or Refractory Multiple Myeloma

Keywords

CC-5013, Revlimid, Lenalidomide, Celgene, Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lenalidomide plus dexamethasone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid®

Intervention Description

Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Description

Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.

Primary Outcome Measure Information:

Title

Kaplan Meier Estimate for Time to Disease Progression

Description

Time Frame

up to 827 days

Secondary Outcome Measure Information:

Title

Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria

Description

Time Frame

Up to 827 days

Title

Participants With Treatment-emergent Adverse Experiences (TEAEs)

Description

Time Frame

up to 8 months

Title

Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria

Description

Time Frame

up to 827 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must understand and voluntarily sign an informed consent form. Must be ≥18 years of age at the time of signing the informed consent form. Must be able to adhere to the study visit schedule and other protocol requirements. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment. Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied. Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1). Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample). Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. Exclusion Criteria: The presence of any of the following will exclude a subject from study enrollment: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or lactating females. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells. Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells. Serum creatinine >2.5 mg/dL (221 µmol/L) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) Serum total bilirubin >2.0 mg/dL (34 µmol/L) Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥1 year. Prior history of stroke and/or thromboembolic event Known hypersensitivity to thalidomide or dexamethasone. Prior history of uncontrollable side effects to dexamethasone therapy. The development of a desquamating rash while taking thalidomide. Neuropathy ≥ Grade 2.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Axel Glasmacher, MD

Organizational Affiliation

University of Bonn

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH

City

Bonn

ZIP/Postal Code

53113

Country

Germany

Facility Name

Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH

City

Braunschweig

ZIP/Postal Code

D-38114

Country

Germany

Facility Name

Interne Klinik Dr. Argirov, Schön-Kliniken

City

Burg

ZIP/Postal Code

82335

Country

Germany

Facility Name

Klinik für Innere Medizin III Klinikum Chemnitz gGmbH

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Medizinische Klinik und Poliklinik, Uniklinikum Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Direktor der Klinik f. Hämatologie, Universitätsklinikum Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Universitätsklinikum EssenInnere Klinik und Poliklinik

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Klinik für Innere Medizin, Klinikum Frankfurt (Oder) GmbH

City

Frankfurt (Oder)

ZIP/Postal Code

15236

Country

Germany

Facility Name

Medizinische Klinik II (ZIM),Hämatologie / Onkologie Uniklinik Frankfurt

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Abt. Innere Medizin I , Hämatologie / Onkologie, Universitätsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitätsklinikum GöttingenHamatologie und Onkologie

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Interdisziplinäre Klinik und Poliklinik für Stammzellentransplantation Universitätsklinik Hamburg - Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

II. Medizinische Abteilung, Asklepios Klinikum Altona

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Abt. Hämatologie, Hämatologie und Onkologie, Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Klinik für Innere Medizin II Hämatologie / Onkologie Universitätsklinikum Jena

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

EPS - Early Phase Solutions GmbH

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Hämatologie / Onkologie / Infektionskrankheiten, Palliativmedizin Städtisches Klinikum Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76135

Country

Germany

Facility Name

2. Med. Klinik , Sektion f. Stammzell- + Immuntherapie Universitätsklinikum Schleswig-Holstein

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Institut für Versorgungsforschung in der Onkologie Praxisklinik für Hämatologie und Onkologie

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hämatologie u. Onkologie

City

Köln

ZIP/Postal Code

50677

Country

Germany

Facility Name

Klinik f. Innere Medizin, Klinikum der Universität zu Köln

City

Köln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Medizinische Klinik und Poliklinik II Abt. Hämatologie / Onkologie, Universitätsklinikum Leipzig AÖR

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

III. Med. Klinik, Johannes Gutenberg Universität

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Klinikum Mannheim der Universität Heidelberg

City

Mannheim

ZIP/Postal Code

68305

Country

Germany

Facility Name

Hämatologisch-Onkologisches Institut für medizinische Service Leistungen

City

Mönchengladbach

ZIP/Postal Code

41239

Country

Germany

Facility Name

Medizinische Klinik III Klinikum der Universität München-Großhadern

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

City

Münster

ZIP/Postal Code

48129

Country

Germany

Facility Name

Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Onkologie Praxis Oldenburg

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

Abt. Onkologie/ Hämatologie, Klinikum Oldenburg

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Abteilung Hämatologie und Onkologie, Hämatologie und Onkologie, Medizinische Klinik, Klinikum Ernst v. Bergmann

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Klinikum der Universität Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Abteilung Hämatologie und Onkologie, Medizinische Fakultät der Universität Rostock

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Caritasklinik St. Theresia

City

Saarbrucken

ZIP/Postal Code

66113

Country

Germany

Facility Name

ms² Medizinische Statistik Saarbrücken

City

Saarbrucken

ZIP/Postal Code

D-66113

Country

Germany

Facility Name

Med. Klinik III , St. Marienkrankenhaus Siegen

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

Zentrum für Innere Medizin II Robert- Bosch-Krankenhaus GmBH

City

Stuttgart

ZIP/Postal Code

D -70376

Country

Germany

Facility Name

Krankenanstalt Mutterhaus der Borromäerinnen

City

Trier

ZIP/Postal Code

54290

Country

Germany

Facility Name

Abt. II Hämatologie, Onkologie und Immunologie Medizinische Klinik Abt.II

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Medizinische Universitätsklinik

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Praxis Dres. Maintz & GroschekHämatologie / Onkologie

City

Wuerselen

ZIP/Postal Code

52146

Country

Germany

Facility Name

Med. Klinik 1, Helios Klinikum Wuppertal

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

Med. Klinik u. Poliklinik IIKlinikum der Universität Würzburg

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Hämatologisch-onkologische Praxis

City

Würzburg

ZIP/Postal Code

D-97070

Country

Germany

12. IPD Sharing Statement

Citations:

Citation

Weisel, Katja Christina, et. al. Speed of Response with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: First Results of the MM-019 Compassionate Use Protocol. 14th Congress of the European Hematology Association, June 2009. Haematologica 2009; 94(Suppl 2):160 abs.0397. http://www.eventure-online.com/eventure/publicAbstractView.do?id=101710&congressId=2432

Results Reference

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A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

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